FDA Enforcement
Class II
Completed
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Recall: Z-0669-2025
·
Reported December 18, 2024
Enforcement
- Recall Number
- Z-0669-2025
- Event ID
- 95781
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Hologic, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2024
- Initiation Date
- October 10, 2022
- Classification Date
- December 11, 2024
- Address
- 250 Campus Dr, Marlborough, MA, 01752-3020, United States
Description
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Reason
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Code Info
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Distribution
US Nationwide distribution.
Quantity
178 units