Device 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.
Z-1692-2023
Product summary
- Event
- Event 92299
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23 cases (52 packs)
- Official record key
device-enforcement:Z-1692-2023
Official wording
Reason: The custom procedure packs contain light handle covers that have been recalled by another firm.
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.
Distribution pattern: US Nationwide distribution in the state of VA.
Derived failure modes
-
Unknown
The custom procedure packs contain light handle covers that have been recalled by another firm.