FDA MedWatch – Surgical Procedure Packs by DeRoyal Industries:

TOPIC: Surgical Procedure Packs by DeRoyal Industries: Class I Recall – Due to Mislabeled Lidocaine

AUDIENCE: Patient, Health Professional, Risk Manager 

ISSUE: DeRoyal is recalling the surgical procedure packs because the packs contain 1% lidocaine that has been mislabeled as 0.5% bupivacaine. Though both lidocaine and bupivacaine are local anesthetics, their dosing is different. If 1% lidocaine is given to the patient instead of 0.5% bupivacaine, the patient may be underdosed and experience pain during the procedure. If 0.5% bupivacaine is given to the patient instead of 1% lidocaine, it may cause an overdose of bupivacaine with potential life threatening or fatal consequences.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: DeRoyal Industries’ surgical procedure packs include a set of devices that are used for routine cardiac procedures such as heart catheterizations, pacemaker-related procedures and x-ray heart imaging (angiogram) procedures.

Each pack includes Hospira Pfizer 1% lidocaine, a local anesthetic that prevents or reduces pain by stopping nerves from sending pain signals during a surgical or catheter procedure.

RECOMMENDATIONS: On May 14, 2021, DeRoyal sent an Urgent Recall Notice to affected customers and provided the following instructions:

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.