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D-0862-2016 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-0862-2016 was initiated by Baxter Healthcare Corp. on Jan 21, 2016 and is designated Class I. Reason for recall: Presence of Particulate Matter: identified as cardboard. The recall status is terminated (terminated Feb 26, 2018). Affected quantity: 273,520 bags.

Recall Details

Product Type: Drugs
Report Date: Jun 1, 2016
Initiation Date: Jan 21, 2016
Termination Date: Feb 26, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 273,520 bags

Product Description

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.

Reason for Recall

Presence of Particulate Matter: identified as cardboard.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: P328997, Exp 01/31/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0862-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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