Z-1692-2023 Class II Ongoing
FDA device recall Z-1692-2023 was initiated by DeRoyal Industries Inc on April 17, 2023 and is designated Class II. Reason for recall: The custom procedure packs contain light handle covers that have been recalled by another firm. The recall status is ongoing. Affected quantity: 23 cases (52 packs).
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 cases (52 packs)
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.
Distribution Pattern
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.