Status
Ongoing
Drug Enforcement D-0062-2023
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Classification
Class II
Report Date
November 23, 2022
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 137,120 bags
- Reason for recall
- Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- ICU Medical Inc
- Address
-
600 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0062-2023
- Event ID
- 91113
- Recall initiation date
- November 9, 2022
- Center classification date
- November 16, 2022
- Code info
- Lot: 5829936, Exp. MAR 31 2024
- More code info
- —