Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73118

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

Open FDA event record

Event summary

Timeline bucket
January 21, 2016
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Drug 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.

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

4 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.

drug · product 1 of 4

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

D-0861-2016
Recall number
D-0861-2016
Initiated
January 21, 2016
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
282,080 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

Code information

Lot #: P337857, Exp 07/31/16

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 4

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

D-0862-2016
Recall number
D-0862-2016
Initiated
January 21, 2016
Classification
Class I
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
273,520 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: identified as cardboard.

Code information

Lot #: P328997, Exp 01/31/2016

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 4

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

D-0863-2016
Recall number
D-0863-2016
Initiated
January 21, 2016
Classification
Class I
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
334,560 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: identified as a cloth fiber.

Code information

Lot #: P339135, Exp 08/31/2017

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 4

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.

D-0864-2016
Recall number
D-0864-2016
Initiated
January 21, 2016
Classification
Class I
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
7,436 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: identified as dried skin.

Code information

Lot #: P333930, Exp 05/31/2017

Distribution pattern

Nationwide and Puerto Rico