Recall Z-1692-2023— DeRoyal Industries Inc

Name: FDA recall Z-1692-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-17

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2023-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.. Reason: The custom procedure packs contain light handle covers that have been recalled by another firm..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-04-17
Firm location: Powell, TN, United States

Product description

Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.

Reason for recall

The custom procedure packs contain light handle covers that have been recalled by another firm.

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