Reported Mar 1, 2023 · Completed
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018,…
B. Braun Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical Inc. · 1845 Mason Ave · Daytona Beach, FL · 32117-5102
Is this the product you have?
- 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
- Lot codes and dates
- Lots
0061794230 Exp. 01/31/20240061794232 Exp. 01/31/20240061797779 Exp. 02/29/20240061797780 Exp. 02/29/20240061797781 Exp. 02/29/20240061797783 Exp. 02/29/20240061797784 Exp. 03/31/20240061797785 Exp. 03/31/20240061797786 Exp. 03/31/20240061797787 Exp. 03/31/20240061797788 Exp. 03/31/20240061809680 Exp. 04/30/2024
- Lots
- Amount recalled
- 483,229 bags
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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