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Recall Observatory FDA recall evidence

Drug 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.

D-1163-2014

November 21, 2013

Class I

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 67092
Status
Terminated
Classification
Class I
Quantity
716,544 containers
Official record key
drug-enforcement:D-1163-2014

Official wording

Reason: 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

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

Distribution pattern: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter