0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.

FDA recall notice · announced May 7, 2014 · Baxter Healthcare

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

The product

0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.

Reason for recall

Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.

Notes

Distribution: nationwide
Lot/code information: Lot # Gl09272; Exp 09/16
Quantity: 211,752 bottles
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. (D-1282-2014)

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