FDA Announces B. Braun’s Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1,000 ml in E3 Containers

August 12, 2024

On August 8, 2024, the U.S. Food and Drug Administration (FDA) announced that (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-1000-ml-e3-containers?utm_medium=email&utm_source=govdelivery) B. Braun Medical Inc. is voluntarily recalling two lots of 0.9% sodium chloride for injection USP 1,000 ml in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.

FDA update

B. Braun said that 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. If the particulates are not sterile, it may lead to embolic phenomena such as stroke or ischemia, infarction in other organs, and infection, any of which could cause potentially life-threatening permanent damage or impairment of body function. To date, the company has not received any customer complaints or reports of serious injury or death associated with this issue.

The following product is affected:

Product Catalog NumberNDC NumberProduct DescriptionLot NumbersDistribution RangeExpiration Date
E80000264-7800-09NACL INJ 0.9%
1000ML – E8000
J2L763,
J2L764
01.Feb.2024 – 28.Feb.202431.Mar.2025

B. Braun has notified its distributors and customers by an official recall notice sent via certified registered mail and has arranged for return of all recalled products. Facilities and distributors that have the recalled product should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862, Monday–Friday, 8 am–6 pm ET, to arrange for product return.

Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to B. Braun’s Postmarket Surveillance Department by calling 833-425-1464.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda).


Copyright © 2024 by the Oncology Nursing Society. User has permission to print one copy for personal or unit-based educational use. Contact pubpermissions@ons.org for quantity reprints or permission to adapt, excerpt, post online, or reuse ONS Voice content for any other purpose.