Recall Z-1834-2021— DeRoyal Industries Inc

Name: FDA recall Z-1834-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-14

Class I · Terminated

Class I FDA medical device recall by DeRoyal Industries Inc, initiated 2021-05-14, terminated 2023-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal Angio Cath Removal Tray, REF 89-9936.02. Reason: 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.

Recalling firm: DeRoyal Industries Inc
Classification: Class I
Status: Terminated
Initiated: 2021-05-14
Terminated: 2023-04-21
Firm location: Powell, TN, United States

Product description

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.