D-0062-2023 Class II Ongoing
FDA drug recall D-0062-2023 was initiated by ICU Medical Inc on Nov 9, 2022 and is designated Class II. Reason for recall: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility. The recall status is ongoing. Affected quantity: 137,120 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 23, 2022
- Initiation Date
- Nov 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 137,120 bags
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
Reason for Recall
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 5829936, Exp. MAR 31 2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0062-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026