Z-0669-2025 Class II
FDA device recall Z-0669-2025 was initiated by Hologic, Inc on October 10, 2022 and is designated Class II. Reason for recall: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set Affected quantity: 178 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- October 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178 units
Product Description
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Reason for Recall
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Distribution Pattern
US Nationwide distribution.
Code Information
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.