Z-0481-2023 Class II Ongoing
FDA device recall Z-0481-2023 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: 80 kits.
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
- 80 kits
Product Description
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
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
a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484