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D-0957-2016 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-0957-2016 was initiated by Baxter Healthcare Corp. on Dec 15, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. The recall status is terminated (terminated Apr 15, 2022). Affected quantity: 255,852 VIAFLEX Plastic Containers.

Recall Details

Product Type: Drugs
Report Date: Jun 15, 2016
Initiation Date: Dec 15, 2015
Termination Date: Apr 15, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 255,852 VIAFLEX Plastic Containers

Product Description

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02

Reason for Recall

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Distribution Pattern

Nationwide

Code Information

Lot # C980227; Exp. 11/16

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0957-2016
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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