Reported Dec 18, 2024 · Completed
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical
- instrument guide Model/Catalog NumberF0101
- Lot codes and dates
- Model No F0101. UDI 15420045515390
- Lot Numbers
186728SS1-200727SS1-181121SS1-190301SS1-190501175517175516162427140718-01171056175515
- Amount recalled
- 178 units
Where it was sold
- Nationwide
Why it was recalled
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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