FDA recall Z-0502-2023

Stradis Medical, LLC dba Stradis Healthcare · Class II · device

Product

HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611

Reason for recall

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Distribution

US nationwide distribution, and Canada.

Key facts

Status: Ongoing
Initiation date: 2022-11-02
Report date: 2022-12-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Peachtree Corners, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2023