Z-0527-2023 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
- 510 units
Product Description
HENRY SCHEIN, Amnio Tray, Item No.570-3059,
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) H65857030591, UDI/DI (kit)M75257030590, Serial/Lot Numbers: 22257487536