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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80641

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

Open FDA event record

Event summary

Timeline bucket
June 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Degania Silicone, Ltd.

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

32 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 32

Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2754-2018
Recall number
Z-2754-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
153

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17005574

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 2 of 32

Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2755-2018
Recall number
Z-2755-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
11488

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17000347, S17000747, S17000805, S17001070, S17005572, S17006024, S17006420

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 3 of 32

Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2756-2018
Recall number
Z-2756-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17005573

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 4 of 32

Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2757-2018
Recall number
Z-2757-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
1588

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17002337, V17003078, V17016095, V17020364

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 5 of 32

Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2758-2018
Recall number
Z-2758-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
475

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17017035, V17014151

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 6 of 32

Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2759-2018
Recall number
Z-2759-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
1028

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17008145, V17022041

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 7 of 32

Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2760-2018
Recall number
Z-2760-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
16350

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17005889, V17010230, V17012903, V17011659, V17017036, V17019527, V17018055, V17026037, V17026408

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 8 of 32

Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2761-2018
Recall number
Z-2761-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
16133

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17018057, V17022043, V17023777, V17018058, V17012115, V17002305, V17002306, V17002308

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 9 of 32

Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2762-2018
Recall number
Z-2762-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
1025

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17018059, V17026475

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 10 of 32

Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2763-2018
Recall number
Z-2763-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
4332

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17002877, S17002878, S17003909, S17004477, S17005607, S17006814, S17005115

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 11 of 32

Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2764-2018
Recall number
Z-2764-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
47520

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17000808, S17000943, S17000946, S17002077, S17001347, S17002197, S17002979, S17003351, S17003439, S17003347, S17003350, S17004190, S17004479, S17004736, S17000809, S17000660, S17001348, S17001349, S17005948, S17005949

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 12 of 32

Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2765-2018
Recall number
Z-2765-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
89122

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17001226, S17002082, S17002550, S17002784, S17002883, S17002884, S17005004, S17003784, S17003785, S17002982, S17002983, S17003916, S17003917, S17004351, S17005957, S17006689, S17007029, S17004746, S17004877, S17005956, S17004486, S17006334, S17005958, S17006206, S17006333, S17006687, S17006688, S17000191, S17000192, S17000231, S17000320, S17000345, S17006690, S17006926, S17007030, S17007032, S17007334, S17007433, S17007434, S17007588, S17008088, S17005116, S17007031, S17003446, S17007599, S17007780, S17000335, S17002083

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 13 of 32

Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2766-2018
Recall number
Z-2766-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
92150

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17002091, S17002440, S17001607, S17002441, S17002558, S17002559, S17002561, S17002562, S17002563, S17002681, S17003391, S17004379, S17002560, S17002682, S17003456, S17003219, S17003301, S17003302, S17004772, S17004376, S17004377, S17004378, S17005117, S17005029, S17005281, S17005983, S17006720, S17004509, S17004510, S17004511, S17004771, S17004902, S17005028, S17005030, S17005529, S17005984, S17005985, S17004380, S17005979, S17006723, S17005980, S17005981, S17005982, S17005986, S17006718, S17006719, S17006721, S17006722, S17006724, S17006725, S17007360, S17007459, S17007622, S17002986, S17006363, S17007623, S17002987, S17007806, S17008017, S17002090

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 14 of 32

Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2767-2018
Recall number
Z-2767-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
12532

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17002333, S17002452, S17002892, S17003578, S17005045, S17003306, S17005046, S17007065, S17005298, S17000279, S17000280, S17000837, S17007171, S18001346, S17000333

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 15 of 32

Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2768-2018
Recall number
Z-2768-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17000350

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 16 of 32

Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2769-2018
Recall number
Z-2769-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17000804

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 17 of 32

Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2770-2018
Recall number
Z-2770-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17006051

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 18 of 32

Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2771-2018
Recall number
Z-2771-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
5000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17006052, S17006060

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 19 of 32

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2772-2018
Recall number
Z-2772-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
1000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17001781, S17002824

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 20 of 32

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2773-2018
Recall number
Z-2773-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17002603

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 21 of 32

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2774-2018
Recall number
Z-2774-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17003321

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 22 of 32

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2775-2018
Recall number
Z-2775-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17003407

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 23 of 32

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2776-2018
Recall number
Z-2776-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

S17006812

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 24 of 32

Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2777-2018
Recall number
Z-2777-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
2784

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17011921, V17026466, V17026467, V17026862

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 25 of 32

Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2778-2018
Recall number
Z-2778-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
14326

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17012299, V17012518, V17012896, V17013267, V17013268, V17013272, V17023765, V17025022, V17025023, V17026861

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 26 of 32

Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2779-2018
Recall number
Z-2779-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
330

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17016090

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 27 of 32

Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2780-2018
Recall number
Z-2780-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
3885

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17023217, V17028046, V17028047

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 28 of 32

Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2781-2018
Recall number
Z-2781-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
4372

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17005426, V17028452, V17028455

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 29 of 32

Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2782-2018
Recall number
Z-2782-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
34627

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17005873, V17009855, V17012488, V17013273, V17016034, V17002138, V17000832

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 30 of 32

Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2783-2018
Recall number
Z-2783-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
2461

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17015592, V17016065

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 31 of 32

Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2784-2018
Recall number
Z-2784-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
1000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17012949

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

device · product 32 of 32

Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Z-2785-2018
Recall number
Z-2785-2018
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
1000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Code information

V17015147

Distribution pattern

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

Field note

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