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Completed

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

FDA Recall Z-0669-2025 · Posted 2024-12-11

Recalling FirmHologic, Inc
Recall StatusCompleted
Product CodeFZX
Date Initiated2022-10-10
Product Quantity178 units

Reason for Recall

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

Firm Action

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:[email protected]

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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