June 28, 2021

FDA: Class I recall of DeRoyal surgical procedure packs

By: Judy Mathias

Tags: FDA, Patient Safety, Patient Safety, Product Recalls, Safety, Treatment Errors

Editor's Note

The Food and Drug Administration (FDA), on June 25, identified the recall of DeRoyal Industries’ surgical procedure packs as Class I, the most serious.

The recall was initiated because the packs contain 1% lidocaine that had been mislabeled as 0.5% bupivacaine.

The procedure packs are used for cardiac procedures, such as heart catheterizations, pacemaker-related procedures, and x-ray imaging (angiogram) procedures.

There have been no deaths, complaints, or reported injuries related to the issue.

FDA: Class I recall of DeRoyal surgical procedure packs

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