Hologic, Inc Recall 95781
Description: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Hologic, Inc Recall 95781 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0669-2025 |
| Event ID | 95781 |
| Event Description | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 178 units |
| Recall Reason | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| Device Classification | 20241218 |
| Device 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. |
| Center Classification Date | 20241211 |
| Recall Initiation Date | 20221010 |
| Recalling Firm | Hologic, Inc |
| Initial Notification | Letter |
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