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D-481-2015 Class I Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA drug recall D-481-2015 was initiated by Baxter Healthcare Corp on Dec 4, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter. The recall status is terminated (terminated Apr 14, 2017). Affected quantity: 542,080 container bags.

Recall Details

Product Type: Drugs
Report Date: Apr 15, 2015
Initiation Date: Dec 4, 2014
Termination Date: Apr 14, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 542,080 container bags

Product Description

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

Reason for Recall

Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot #: P317891, P317842, Exp 05/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-481-2015
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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