Recalls / Class II
Class IID-0062-2023
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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0990-7730, 0990-7983, 0990-7984, 0990-7985
- FDA application
- NDA018090
- Affected lot / code info
- Lot: 5829936, Exp. MAR 31 2024
Why it was recalled
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Recalling firm
- Firm
- ICU Medical Inc
- Manufacturer
- ICU Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 137,120 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-11-09
- FDA classified
- 2022-11-16
- Posted by FDA
- 2022-11-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0062-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.