FDA recall Z-1111-2022

Product

Turbett Surgical Container, TS1500

Reason for recall

Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

Distribution

Domestic distribution to PA, CA, and NY only.

Key facts

Status

Ongoing

Initiation date

2022-04-01

Report date

2022-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Victor, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2022