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Safety Report: B. Braun 0.9% Sodium Chloride for Injection - recalled due to particulate matter and fluid leakage, USA

1 month ago •source fda.gov

Recall notice

B. Braun 0.9% Sodium Chloride for Injection - recalled due to particulate matter and fluid leakage photo #1

United States

B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers. The product was distributed Nationwide within the United States to domestic distributors.

Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.

The product recalled is 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers, Product Code: E8000, NDC Number: 0264-7800-09, Lot Number: J2L763, J2L764, Distribution Range: 01.Feb.2024 – 28.Feb.2024, Expiration Date: 31.Mar.2025. The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage.

Facilities and distributors that have product which is being recalled should discontinue use immediately and return of all recalled products.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: B. Braun Medical Inc.
Brand name: B Braun
Product recalled: 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers
Reason of the recall: Potential for particulate matter and fluid leakage of the containers
FDA Recall date: August 08, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-1000-ml-e3-containers

#drugs #recall #us

323

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