Medline Issues Class I Recall for Kits Containing Contaminated Pain Management Components

Medline has issued a Class I recall, the most serious type, for specific convenience kits containing ICU Medical, Inc. pain management components affected by a prior recall of Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.

This correction addresses significant health risks associated with the compromised injectables, including infection, inflammatory response, and reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination, meningitis, and encephalitis, potentially requiring emergency conversion to general anesthesia.

Medline has advised affected customers to correct their kits by removing the implicated components. As of June 8, Medline has not reported any serious injuries or deaths related to this issue. Customers with questions should contact Medline Industries.