FDA Recall D-1163-2014

Baxter Healthcare Corp. · Deerfield, IL

Class I — life-threatening Terminated 1035 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Lot / code: Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14

Quantity: 716,544 containers

Reason for recall

Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Recall record

Recall number: D-1163-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Recall initiated: 2013-11-21
Classified by FDA Center: 2014-03-14
FDA published: 2014-03-26
Terminated: 2016-09-21
Recalling firm: Baxter Healthcare Corp.
Firm location: Deerfield, IL

Drug identification

Brand name(s): SODIUM CHLORIDE
Generic name(s): SODIUM CHLORIDE
Manufacturer(s): Baxter Healthcare Corporation
NDC(s): 0338-0043, 0338-0049
Route(s): INTRAVENOUS

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