FDA Classifies Medline Convenience Kit Recall as Class I
FDA has classified the recall of certain Medline convenience kits containing B. Braun bupivacaine hydrochloride components as Class I. Medline Industries, LP is correcting affected kits because they include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP that was recalled for quality issues.
Decision support
Decision summary
FDA-sourced recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Medline Industries, LP is correcting certain convenience kits that contain B. Braun components including Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA has classified the action as Class I. FDA states that the affected injectable was recalled for quality issues and that compromised injectables may cause infection, inflammatory response, or reduced anesthetic effectiveness, potentially requiring emergency conversion to general anesthesia. When used in the neuraxial space, FDA also identifies a risk of cerebral fluid contamination and meningitis that may progress to encephalitis. The action is a correction: affected kits are not removed from where they are used or sold.
MedTech Current analysis
Why it matters
An upstream injectable-component quality issue can extend into multiple surgical convenience-kit configurations. Organizations must identify affected item and lot numbers before continued use, then control the affected component within the kit. FDA reported 35 serious injuries and no deaths associated with the underlying issue as of April 24; Medline reported no additional serious injuries or deaths as of June 19.
Official recall information
Official actions
According to the FDA communication:
- Check stock for affected item and lot numbers and quarantine affected product.
- Submit the recall response form to receive over-labels for affected inventory.
- Use the over-label instructions to remove and discard the affected component before using the kit.
- Forward the recall notice to consignees if affected product was further distributed.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
FDA classified Medline’s correction of specified convenience kits as Class I. The kits must be identified by the affected item and lot numbers, then corrected before use by removing and discarding the affected injectable component as instructed in the FDA communication.
Scope and response
The FDA notice identifies 13 affected kit families used in surgical settings for pain management and regional anesthesia. The three FDA database records list 2,417 kits in commerce. Facilities should follow their normal recall-control process and retain the FDA communication as the source of the complete affected-product list.