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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun Sodium Chloride Injection Recalled for Sterility Concerns and Leakage

Agency Publication Date: February 23, 2023
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Summary

B. Braun Medical Inc. has recalled 1,827,211 bags of 0.9% Sodium Chloride Injection, USP, in 1000 mL and 500 mL EXCEL Plus containers. The recall was initiated because the bags may have an incomplete seal, leading to microscopic leaks near the port assembly. These saline injections are used to replace fluids and salts in patients at hospitals and healthcare facilities. There have been no reports of injuries to date.

Risk

A compromise in the bag's seal can result in a loss of sterility, potentially allowing bacteria to enter the saline solution and causing serious infection in patients receiving the intravenous injection.

What You Should Do

  1. This recall affects 1000 mL and 500 mL EXCEL Plus containers of B. Braun 0.9% Sodium Chloride Injection, USP, which is a sterile saline solution for intravenous use.
  2. Identify affected products by checking the label for NDC 0264-5802-00 (1000 mL) or NDC 0264-5802-10 (500 mL) and the specific lot numbers printed on the bag. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1000 mL)by B. Braun
Variants: 1000 mL, Excel Plus Container
Lot Numbers:
0061786962 (Exp. 11/30/2023)
0061797767 (Exp. 04/30/2024)
0061797768 (Exp. 05/31/2024)
0061787769 (Exp. 05/31/2024)
0061797770 (Exp. 05/31/2024)
0061797771 (Exp. 05/31/2024)
0061797772 (Exp. 05/31/2024)
0061797773 (Exp. 05/31/2024)
0061797774 (Exp. 05/31/2024)
0061797775 (Exp. 05/31/2024)
0061797776 (Exp. 05/31/2024)
0061812946 (Exp. 05/31/2024)
0061812947 (Exp. 05/31/2024)
0061812948 (Exp. 05/31/2024)
0061812949 (Exp. 05/31/2024)
0061812950 (Exp. 05/31/2024)
0061816017 (Exp. 06/30/2024)
0061816018 (Exp. 06/30/2024)
0061816019 (Exp. 06/30/2024)
0061816020 (Exp. 06/30/2024)
0061816021 (Exp. 06/30/2024)
0061816358 (Exp. 06/30/2024)
0061816359 (Exp. 06/30/2024)
0061816361 (Exp. 07/31/2024)
0061816362 (Exp. 07/31/2024)
0061816363 (Exp. 07/31/2024)
0061816364 (Exp. 07/31/2024)
0061818516 (Exp. 07/31/2024)
0061818517 (Exp. 07/31/2024)
0061818518 (Exp. 07/31/2024)
0061821562 (Exp. 08/31/2024)
0061821563 (Exp. 08/31/2024)
0061821564 (Exp. 08/31/2024)
0061823709 (Exp. 08/31/2024)
0061823710 (Exp. 08/31/2024)
0061823711 (Exp. 08/31/2024)
0061823714 (Exp. 08/31/2024)
0061823715 (Exp. 08/31/2024)
0061823716 (Exp. 08/31/2024)
0061824770 (Exp. 08/31/2024)
0061824771 (Exp. 08/31/2024)
0061824772 (Exp. 08/31/2024)
0061824773 (Exp. 08/31/2024)
0061824774 (Exp. 08/31/2024)
0061824775 (Exp. 08/31/2024)
0061824776 (Exp. 08/31/2024)
0061824777 (Exp. 08/31/2024)
0061826486 (Exp. 08/31/2024)
0061826487 (Exp. 08/31/2024)
0061826488 (Exp. 08/31/2024)
NDC:
0264-5802-00

Rx Only. Bethlehem, PA 18018.

Product: 0.9% Sodium Chloride Injection, USP (500 mL)by B. Braun
Variants: 500 mL, Excel Plus Container
Lot Numbers:
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)
NDC:
0264-5802-10

Rx Only. Bethlehem, PA 18018.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91658
Status: Resolved
Manufacturer: B. Braun Medical Inc.
Sold By: Hospitals; Healthcare facilities; Pharmacies
Manufactured In: United States
Units Affected: 2 products (1,343,982 bags; 483,229 bags)
Distributed To: Nationwide
Agency Last Updated: March 7, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.