FDA Announces B. Braun’s Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1,000 ml in E3 Containers
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.
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 Number | NDC Number | Product Description | Lot Numbers | Distribution Range | Expiration Date |
|---|---|---|---|---|---|
| E8000 | 0264-7800-09 | NACL INJ 0.9% 1000ML – E8000 | J2L763, J2L764 | 01.Feb.2024 – 28.Feb.2024 | 31.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).