FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1692-2023
·
Reported June 14, 2023
Enforcement
- Recall Number
- Z-1692-2023
- Event ID
- 92299
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2023
- Initiation Date
- April 17, 2023
- Classification Date
- June 7, 2023
- Address
- 200 Debusk Ln, Powell, TN, 37849-4703, United States
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
The custom procedure packs contain light handle covers that have been recalled by another firm.
Code Info
(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
US Nationwide distribution in the state of VA.
Quantity
23 cases (52 packs)