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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90967

45 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 02, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Carefusion 2200 Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

45 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 45

CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000

Z-0373-2023
Recall number
Z-0373-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
1369 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040702, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 2 of 45

CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002

Z-0374-2023
Recall number
Z-0374-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
418 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040719, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 3 of 45

Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4" (195MM), REF F-1003

Z-0375-2023
Recall number
Z-0375-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
347 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040726, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 4 of 45

Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1030

Z-0376-2023
Recall number
Z-0376-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
218 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040733, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 5 of 45

Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035

Z-0377-2023
Recall number
Z-0377-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040740, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 6 of 45

Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040

Z-0378-2023
Recall number
Z-0378-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
203 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040757, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 7 of 45

Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045

Z-0379-2023
Recall number
Z-0379-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
119 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040764, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 8 of 45

Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110

Z-0380-2023
Recall number
Z-0380-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040771, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 9 of 45

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111

Z-0381-2023
Recall number
Z-0381-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040788, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 10 of 45

Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112

Z-0382-2023
Recall number
Z-0382-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040795, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 11 of 45

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113

Z-0383-2023
Recall number
Z-0383-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
259 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040801, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 12 of 45

Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300

Z-0384-2023
Recall number
Z-0384-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
146 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040818, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 13 of 45

Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301

Z-0385-2023
Recall number
Z-0385-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040825, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 14 of 45

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303

Z-0386-2023
Recall number
Z-0386-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
52 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040832, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 15 of 45

Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304

Z-0387-2023
Recall number
Z-0387-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040849, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 16 of 45

Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305

Z-0388-2023
Recall number
Z-0388-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
132 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040856, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 17 of 45

Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335

Z-0389-2023
Recall number
Z-0389-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040870, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 18 of 45

Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180MM), REF F-2002

Z-0390-2023
Recall number
Z-0390-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
128 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040900, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 19 of 45

Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004

Z-0391-2023
Recall number
Z-0391-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
1810 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040917, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 20 of 45

Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000

Z-0392-2023
Recall number
Z-0392-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
236 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040924, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 21 of 45

Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007

Z-0393-2023
Recall number
Z-0393-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040955, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 22 of 45

Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010

Z-0394-2023
Recall number
Z-0394-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
1063 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040962, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 23 of 45

CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015

Z-0395-2023
Recall number
Z-0395-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
4557 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040979, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 24 of 45

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002

Z-0396-2023
Recall number
Z-0396-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403040986, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 25 of 45

CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006

Z-0397-2023
Recall number
Z-0397-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
2 unist

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041006, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 26 of 45

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008

Z-0398-2023
Recall number
Z-0398-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

UDI/DI 10885403041013, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 27 of 45

CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010

Z-0399-2023
Recall number
Z-0399-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041020, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 28 of 45

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014

Z-0400-2023
Recall number
Z-0400-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041044, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 29 of 45

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016

Z-0401-2023
Recall number
Z-0401-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041051, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 30 of 45

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018

Z-0402-2023
Recall number
Z-0402-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041068, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 31 of 45

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022

Z-0403-2023
Recall number
Z-0403-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041075, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 32 of 45

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061

Z-0404-2023
Recall number
Z-0404-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041136, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 33 of 45

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5067

Z-0405-2023
Recall number
Z-0405-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041167, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 34 of 45

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069

Z-0406-2023
Recall number
Z-0406-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041174, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 35 of 45

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5073

Z-0407-2023
Recall number
Z-0407-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041198, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 36 of 45

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124

Z-0408-2023
Recall number
Z-0408-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041204, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 37 of 45

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125

Z-0409-2023
Recall number
Z-0409-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041211, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 38 of 45

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126

Z-0410-2023
Recall number
Z-0410-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041228, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 39 of 45

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127

Z-0411-2023
Recall number
Z-0411-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041235, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 40 of 45

CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128

Z-0412-2023
Recall number
Z-0412-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
79 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041242, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 41 of 45

CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5301

Z-0413-2023
Recall number
Z-0413-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
201 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041266, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 42 of 45

CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302

Z-0414-2023
Recall number
Z-0414-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
147 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041273, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 43 of 45

CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303

Z-0415-2023
Recall number
Z-0415-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
142 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041280, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 44 of 45

CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304

Z-0416-2023
Recall number
Z-0416-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041297, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

device · product 45 of 45

CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000

Z-0417-2023
Recall number
Z-0417-2023
Initiated
November 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Carefusion 2200 Inc
Quantity
239 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

Code information

UDI/DI 10885403041297, ALL LOTS

Distribution pattern

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

Field note

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