|
Convenience Kit Recall: Certain B. Braun Spinal Anesthesia Kits
The FDA is aware that B. Braun Medical, Inc. has issued a letter to affected customers recommending spinal anesthesia kits containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, be removed from where they are used or sold.
On April 2, Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP. Risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis and emergency conversion to general anesthesia.
As of April 24, B. Braun has reported 35 serious injuries and no deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun Medical, Inc. at recalls@bbraunusa.com, or via phone at (844) 903-6417.
|
