0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

FDA recall notice · announced November 23, 2022 · Icu Medical

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 flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Reason for recall

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 5829936, Exp. MAR 31 2024
Quantity: 137,120 bags
Status: Ongoing
Products in this recall event:
- 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 (D-0062-2023)

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