Updated: Jul 24, 2021
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. There have been no deaths, complaints, or reported injuries related to this issue. This recall is related to a Hospira recall for the same mislabeling issue. 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:
Identify affected surgical packs and discontinue their use
Hold packs affected by this recall separately to ensure they are not used
Complete a form (provided with the recall notice) to inform the company of affected products on hand, even if no products are found in inventory, and return it
Return entire surgical packs to DeRoyal
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.