FDA recall Z-1038-2023

Turbett Surgical, Inc. · Class II · device

Product

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Reason for recall

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

Distribution

US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

Key facts

Status
Ongoing
Initiation date
2022-12-05
Report date
2023-02-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Victor, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1038-2023