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Beaver Visitec International, Inc. recalls CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures
Recalled May 10, 2023 · FDA recall Z-1497-2023 · Beaver Visitec International
Hazard
Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure. · FDA Class II
Units
501 (USA)
Sold at
US Nationwide distribution.
Description
Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
Product
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
Manufacturer(s)
Beaver Visitec International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →