Z-0492-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- November 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 units
Product Description
Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
Reason for Recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Distribution Pattern
US nationwide distribution, and Canada.
Code Information
UDI/DI (case) M75240996WLS1, UDI/DI (kit)M75240996WLS0, Serial/Lot Numbers: 22230489371