FDA Device

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06

Hazard

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

What You Should Do

Remedy

The firm initiated the recall by email on May 14, 2021. The notice explained the problem and hazard,. Customers were instructed to complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. and return to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com Customers were asked to PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. Distributors were instructed to notify their customers.

Products

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Brand
DeRoyal Industries Inc
UPC
Lot Number 54239375, exp. 02/01/2022

Units Affected

12 trays