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

FDA device recall Z-0669-2025 · posted 2024-12-11 · Completed

Recall details

Recalling firm

Hologic, Inc

Reason for recall

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

Action taken

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:BreastHealth.Support@hologic.com

Root cause

Labeling Change Control

Status

Completed

Product code

FZX

Quantity affected

178 units

Distribution

US Nationwide distribution.

Date initiated

2022-10-10

Date posted

2024-12-11

Location

Marlborough, MA