Hologic recall
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Why was Hologic recalled?
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
- Product
- Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- Recalling firm
- Hologic, Inc
- Quantity
- 178 units
- Distribution
- US Nationwide distribution.
- Recall date
- December 18, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)