0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

FDA recall notice · announced March 6, 2013 · Hospira

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

The product

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

Reason for recall

Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.

Notes

Distribution: Nationwide
Lot/code information: Lot 13-121-JT* * the lot number may be followed by 01
Quantity: 56,854 Units
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 (D-176-2013)

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