Recall Z-0669-2025
Hologic, Inc · initiated October 10, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Codes / lots: Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Reason for recall
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
FDA-determined cause: Labeling Change Control
Action taken
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 material (or one layer of 1 ply wrap) is necessary to provide a sterile barrier for each sterilization tray. Please do not utilize 2 layers or one layer of 2-ply wrap. In the future, Hologic will be updating the IFU supplied with the sizers within F0101, to reflect this change. mailto:BreastHealth.Support@hologic.com
Details
- Recall number
- Z-0669-2025
- Initiated
- October 10, 2022
- Posted by FDA
- December 11, 2024
- Product code
- FZX – Guide, Surgical, Instrument
- Quantity
- 178 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Hologic, Inc, Marlborough, MA