0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

FDA recall notice · announced July 31, 2019 · Baxter Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

Reason for recall

Lack of Assurance of Sterility: Bags have potential to leak.

Notes

Distribution: Nationwide in the United States and Puerto Rico.
Lot/code information: Lot #s: P389684; P389742, Exp. 8/31/2020
Quantity: 139,680 Containers
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38. (D-1514-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.