Devices

Medline Convenience Kit Recall is Class 1

Medline has issued a device correction (Class 1 recall) for convenience kits containing B. Braun’s bupivacaine hydrochloride components. An FDA notice says Medline issued a letter to affected customers recommending that certain Medline convenience kits be corrected prior to continued use by removing components affected by the B. Braun Medical, Inc. recall. Affected devices:

Medline Anterior Hip Kits
Medline C-Section kits
Medline MHCZ Total Knee Kits
Medline Posterior Hip Kits
Medline Total Hip Kits
Medline Total Hip w/ Navigation No Syringe Kits
Medline Total Hip - LF Kits
Medline Total Joint Kits
Medline Total Knee Kits
Medline Total Knee Basic Kits
Medline Total Knee w/ Navigation Kits
Medline Total Knee W/ Navigation No Syringe Kits
Medline Total Knee – LF Kits

FDA says the “risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness which can lead to emergency conversion to general anesthesia. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis.”

As of April 24, B. Braun has reported 35 serious injuries and no deaths associated with the issue, the agency says. As of June 19, Medline has not reported any additional serious injuries or deaths associated with this issue, it adds.

The kits involved in this recall are used for pain management and regional anesthesia.

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