Exact FDA event identifier

Event 81881

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

Event summary

Timeline bucket: January 02, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Baxter Healthcare Corporation

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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 Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

D-0351-2019

Recall number: D-0351-2019
Initiated: January 02, 2019
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corporation
Quantity: 29,370 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: Confirmed customer complaints for leaks on the tubing.

Code information

Lot #: Y281477, Expiry: 02/2020

Distribution pattern

Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.