FDA-Device2024-12-18Class II
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Hazard
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Sold states
US Nationwide distribution.
Affected count
178 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2025More Hologic, Inc recalls
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