The FDA has classified a recall of spinal anesthesia kits from B. Braun Medical as Class I, the agency’s most serious designation, according to a July 17 Citeline report.
The recalled kits contain bupivacaine hydrochloride in dextrose injection, a prescription local anesthetic. The FDA said the recall has been linked to 35 serious injuries. In a letter to customers, B. Braun instructed providers to remove affected kits from inventory and stop using them.
A Class I recall is issued when there is a reasonable probability that use of or exposure to a product could cause serious adverse health consequences or death. The FDA has posted additional information, including affected product details, on its recall website.
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