FDA-Device2022-05-25Class II

Turbett Surgical Container, TS1500

TURBETT SURGICAL, LLC
Hazard

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

Sold states
Domestic distribution to PA, CA, and NY only.
Affected count
232 units
Manufactured in
668b Phillips Rd Ofc 1, N/A, Victor, NY, United States
Products
Turbett Surgical Container, TS1500

Official notice

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

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