Recall Z-0669-2025 ยท FZX Guide, Surgical, Instrument
Hologic, Inc
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
| Date | Dec 11, 2024 (initiated Oct 10, 2022) |
| Status | Completed |
| Reason | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| Root cause | Labeling Change Control |
| Action | Hologic issued Letter-Revised Sterilization Instructions for Sizer Set on 10/10/22 via Fed'X. The letter states reason for recall, health risk and action to take: Effective immediately, please steam autoclave F0101 in accordance with such IFU, subject to the following parameters. Any additional parameters contained in Hologic s IFU for F0101 should no longer be utilized. link to their Instructions for Use (IFU) below: https://summitmedicalusa.com/wordpress/wp-content/uploads/2021/05/40192-01_RevZ_IS-IFU_Multilingual.pdf Please also note that when sterilizing F0101, one (1) layer of wrapping |
| Quantity | 178 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.