0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
FDA recall notice · announced August 26, 2015 · Baxter Healthcare
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
Reason for recall
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Notes
Distribution: Nationwide
Lot/code information: Lot#: P319921, Exp 12/15
Quantity: 189,120 bags
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-1 (D-1335-2015)
- 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11. (D-1336-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.