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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67608

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 11, 2014
Product types
Drug
Classifications
Class I
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

1 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 1

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11

D-1276-2014
Recall number
D-1276-2014
Initiated
February 11, 2014
Classification
Class I
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
27,169 containers

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

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Code information

Lot number: C903799, Exp 05/15

Distribution pattern

Nationwide.