DeRoyal Industries Recalls Pacemaker, Heart, and Angio Cath Trays Due to Dangerous Lidocaine Labeling Error
The U.S. Food and Drug Administration has issued a Class I recall for three DeRoyal Industries surgical procedure packs due to a potentially deadly anesthetic labeling error. Class I recalls are the most severe kind of recall issued by the U.S. FDA are applied to products that may cause serious injuries or death.
Einnews.com reported on June 25, 2021, that DeRoyal Industries had recalled three surgical procedure packs/trays, including an assemblage of medical devices that are used for routine cardiac surgical procedures such as x-ray heart imaging (angiogram), heart catheterizations, and pacemaker-related procedures.
Each of the recalled surgical packs listed below includes Hospira Pfizer 1% lidocaine, a local anesthetic that reduces or prevents pain by obstructing nerves from transmitting pain signals during a catheter or surgical procedure.
The Reason for Recall
DeRoyal Industries has initiated the surgical procedure pack recalls due to the packs containing 1% lidocaine were incorrectly labeled as 0.5% bupivacaine. Although lidocaine and bupivacaine are both local anesthetics, the dosing between the two is different. Should 1% lidocaine be administered to a patient instead of 0.5% bupivacaine, the patient will be underdosed and will experience pain during the surgical procedure. If 0.5% bupivacaine is administered to a patient instead of 1% lidocaine, the patient could be accidentally overdosed, resulting in life-threatening or fatal outcomes. This recall is connected to Hospira’s mislabeling recall.
The Recalled DeRoyal Surgical Products:
DeRoyal Pacemaker Tray Pgybk
Lot Number 54239375, exp. 02/01/2022
DeRoyal Heart Cath Procedure Pack
Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022
DeRoyal Angio Cath Removal Tray
Lot Numbers: 54368716, exp. 06/01/2022
On May 14, 2021, DeRoyal Industries distributed an Urgent Recall Notice to medical professionals and affected customers. DeRoyal is instructing medical professionals to “identify affected surgical packs and discontinue their use.” Customers who have a recalled product are asked to complete the form that was sent with the recall notice or visit deroyal.com for additional information.
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