Recalls / Class II
Class IID-0347-2023
Product
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0264-5802, 0264-5804
- FDA application
- NDA019635
- Affected lot / code info
- Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
Why it was recalled
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Recalling firm
- Firm
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1845 Mason Ave, N/A, Daytona Beach, Florida 32117-5102
Distribution
- Quantity
- 483,229 bags
- Distribution pattern
- USA Nationwide.
Timeline
- Recall initiated
- 2023-02-10
- FDA classified
- 2023-02-23
- Posted by FDA
- 2023-03-01
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0347-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.