FDAFDA · Food and drugs·Recall number Z-0669-2025
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Published December 18, 2024 · Recall initiated: October 10, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc
- Distributor
- US Nationwide distribution.
- Lot
- Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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