Z-0504-2023 Class II Ongoing
FDA device recall Z-0504-2023 was initiated by Stradis Medical, LLC dba Stradis Healthcare on November 2, 2022 and is designated Class II. 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 th… The recall status is ongoing. Affected quantity: 15 units.
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
- 15 units
Product Description
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general 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) H65857014621, UDI/DI (kit)M75257014620, Serial/Lot Numbers: 22230491082