Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Va...
FDA Recall #Z-1692-2023 — Class II — April 17, 2023
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.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
23 cases (52 packs)
Distribution
US Nationwide distribution in the state of VA.
Code Information
(1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated