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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83509

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

Open FDA event record

Event summary

Timeline bucket
September 21, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
The Metrix Company

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

8 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 8

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0001-2020
Recall number
Z-0001-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
1596 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: 66615-A3539, 66615-A5098

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 2 of 8

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0002-2020
Recall number
Z-0002-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
4284 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: 66630-A2771, 66630-A4282

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 3 of 8

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0003-2020
Recall number
Z-0003-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
1512 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: 66640-A2404, 66640-A4324

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 4 of 8

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0004-2020
Recall number
Z-0004-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
141120 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: 66616-A2442, 66616-A2524, 66616-A2725, 66616-A2906, 66616-A2974, 66616-A3033, 66616-A3309, 66616-A3310, 66616-A3318, 66616-A3520, 66616-A3554, 66616-A3559, 66616-A3737, 66616-A3773, 66616-A3794, 66616-A3977, 66616-A4081, 66616-A4147, 66616-A4443, 66616-A4516, 66616-A5064, 66616-A5281, 66616-A5410, 66616-A5550, 66616-A5669

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 5 of 8

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0005-2020
Recall number
Z-0005-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
234720 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: 66631-A2443, 66631-A2564, 66631-A2629, 66631-A2772, 66631-A2975, 66631-A3004, 66631-A3311, 66631-A3456, 66631-A3483, 66631-A3553, 66631-A3558, 66631-A3738, 66631-A3774, 66631-A3795, 66631-A3978, 66631-A4082, 66631-A4148, 66631-A4444, 66631-A4517, 66631-A5065, 66631-A5282, 66631-A5411, 66631-A5555, 66631-A5670

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 6 of 8

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0006-2020
Recall number
Z-0006-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
54720 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: 66641-A2630, 66641-A2683, 66641-A3005, 66641-A3560, 66641-A3796, 66641-A3979, 66641-A4220, 66641-A4473, 66641-A4543, 66641-A5066, 66641-A5283, 66641-A5412, 66641-A5556, 66641-A5671

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 7 of 8

ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0007-2020
Recall number
Z-0007-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
175392 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

device · product 8 of 8

ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0008-2020
Recall number
Z-0008-2020
Initiated
September 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
The Metrix Company
Quantity
332640 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaking product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaking product

Code information

Lot Numbers: H938905 63630-A1769, H938905 63630-A1771, H938905 63630-A1773, H938905 63630-A2647, H938905 63630-A2649, H938905 63630-A2651, H938905 63630-A2655, H938905 63630-A2657, H938905 63630-A2659, H938905 63630-A2661, H938905 63630-A3950, H938905 63630-A3952, H938905 63630-A3954, H938905 63630-A3956, H938905 63630-A3957, H938905 63630-A3959, H938905 63630-A3961, H938905 63630-A3963, H938905 63630-A3965, H938905 63630-A3968, H938905 63630- A5338, H938905 63630-A5340, H938905 63630-A5342, H938905 63630-A5344, H938905 63630-A5346, H938905 63630-A5348, H938905 63630-A5350

Distribution pattern

US Nationwide distribution including the states of PA, MA, IL CA.

Field note

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