—#187486

Product

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: Lot Number 54239375, exp. 02/01/2022

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US Nationwide distribution to the states of MS, VA, LA, and NY.

Timeline

Recall initiated: 2021-05-14
Posted by FDA: 2021-06-10
Terminated: 2023-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187486. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.