According to the FDA, B. Braun Medical Inc. (B. Braun), of Bethlehem, Pennsylvania, has recalled two lots of its 0.9 Sodium Chloride for Injection USP 1000 mL in E3 containers because the product may contain particulate matter, and its containers may potentially leak fluid.
The voluntary, nationwide recall was initiated after officials learned that the batches in question were accidentally distributed for sale without having completed the “acceptance activities” required for the product’s “embedded particulate matter,” which makes the containers prone to leakage.
Affected products, which were distributed in the U.S. between February 1, 2024, and February 28, 2024, can be identified by the following information, as shown in the photo included in the FDA communication:
- Product Catalog Number: E8000
- NDC Number: 0264-7800-09
- Product Description: NACL INJ 0.9%1000ML – E8000
- Lot Number: J2L763, J2L764
- Expiration Date: March 31, 2025
While B. Braun has not received any complaints or reports of major injuries or death in connection to the problem, if particulates found in the product turn out not to be sterile, there is a reasonable likelihood that users may suffer embolic phenomena such as “stroke or ischemia/infarct to other organs,” as well as a potential infection. These conditions could then permanently damage or impair bodily functions in a manner that may be life-threatening.
Indicated for use by adult and pediatric patients, 0.9 Sodium Chloride for Injection USP 1000 mL in E3 containers is an intravenous solution and a source of hydration, containing electrolytes and water. The solution also has a number of other applications:
- as an “extracellular fluid replacement” which treats metabolic alkalosis in those suffering loss of fluid or a mild depletion of sodium,
- as a priming agent in hemodialysis procedures,
- as a method of “[initiating] and [terminating] blood transfusions without hemolyzing,” or destroying, red blood cells, and
- as “a pharmaceutic aid and diluent for the infusion of compatible drug additives.”
Since the recall, announced on the FDA site on August 8, 2024, B. Braun distributors and customers have been alerted via an official notice delivered through certified registered mail. A return program for all recalled products has also been established. Any recalled product which might still be in the possession of facilities or distributors should no longer be used or distributed. To arrange for the return of recalled products, customers should reach out to the B. Braun Medical Inc. Customer Support Department by calling 800-227-2862. Representatives are available Monday through Friday, from 8:00 a.m. to 6:00 p.m. Eastern Time.
As the FDA continues to oversee this recall, the agency asks that any adverse outcomes or quality issues be reported to its MedWatch Adverse Event Reporting program.
If you or a loved one has suffered an adverse health outcome after being administered a compromised or contaminated medical product, our dedicated attorneys at TruLaw would like to help you fight for maximum compensation. After a traumatic and potentially life-threatening medical medical event, your case warrants a full investigation and your family deserves justice. To learn about how we can support you during this time, contact us or take our free Instant Case Evaluation ℠.