Reported Mar 1, 2023 · Completed
0.9% Sodium Chloride Injection, USP, 1000 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, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
- Lot codes and dates
- Lots
0061786962 Exp. 11/30/20230061797767 Exp. 04/30/20240061797768 Exp. 05/31/20240061787769 Exp. 05/31/20240061797770 Exp. 05/31/20240061797771 Exp. 05/31/20240061797772 Exp. 05/31/20240061797773 Exp. 05/31/20240061797774 Exp. 05/31/20240061797775 Exp. 05/31/20240061797776 Exp. 05/31/20240061812946 Exp. 05/31/20240061812947 Exp. 05/31/20240061812948 Exp. 05/31/20240061812949 Exp. 05/31/20240061812950 Exp. 05/31/20240061816017 Exp. 06/30/20240061816018 Exp. 06/30/20240061816019 Exp. 06/30/20240061816020 Exp. 06/30/20240061816021 Exp. 06/30/20240061816358 Exp. 06/30/20240061816359 Exp. 06/30/20240061816361 Exp. 07/31/20240061816362 Exp. 07/31/20240061816363 Exp. 07/31/20240061816364 Exp. 07/31/20240061818516 Exp. 07/31/20240061818517 Exp. 07/31/20240061818518 Exp. 07/31/20240061821562 Exp. 08/31/20240061821563 Exp. 08/31/20240061821564 Exp. 08/31/20240061823709 Exp. 08/31/20240061823710 Exp. 08/31/20240061823711 Exp. 08/31/20240061823714 Exp. 08/31/20240061823715 Exp. 08/31/20240061823716 Exp. 08/31/20240061824770 Exp. 08/31/20240061824771 Exp. 08/31/20240061824772 Exp. 08/31/20240061824773 Exp. 08/31/20240061824774 Exp. 08/31/20240061824775 Exp. 08/31/20240061824776 Exp. 08/31/20240061824777 Exp. 08/31/20240061826486 Exp. 08/31/20240061826487 Exp. 08/31/20240061826488 Exp. 08/31/2024
- Lots
- Amount recalled
- 1,343,982 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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