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D-1591-2014 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1591-2014 was initiated by Baxter Healthcare Corp. on Jul 11, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. The recall status is terminated (terminated Sep 21, 2016). Affected quantity: a) 217,536 bags; b) 161,760 bags.

Recall Details

Product Type: Drugs
Report Date: Sep 24, 2014
Initiation Date: Jul 11, 2014
Termination Date: Sep 21, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 217,536 bags; b) 161,760 bags

Product Description

0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Reason for Recall

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Distribution Pattern

Nationwide, Puerto Rico, Singapore, and Hong Kong

Code Information

Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1591-2014
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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