Friday, June 25, 2021

DeRoyal Recalls Surgical Procedure Packs for Mislabeled Lidocaine

Serious injuries or death may result from the use of these devices. The FDA has identified this as a Class I recall, the most serious type.

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FDA - Center for Devices and Radiological Health

DeRoyal Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine

DeRoyal is recalling the surgical procedure packs because the packs contain 1% lidocaine that has been mislabeled as 0.5% bupivacaine. This recall is related to Hospira's recall for the same mislabeling issue.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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Questions?

If you have questions about this recall, contact the Division of Industry and Consumer Education.


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