Beaver Visitec International, Inc.: CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized t

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 501 (USA) Lot/code info: GTIN: 08719214223458 All Affected Lots: 20214450, 20214366, 20214367, 20214518, 20214522, 20214615, 20214744, 20214745, 20214961, 20214962, 20215203, 20215204, 20215479, 20216263, 20216264, 20216010, 20227952, 20227950, 20227951, 20228408, 20228657, 20228897, 20228898, 20229034, 20229138, 20229334, 20229460, 20229630, 20229748, 20230261, 20221083, 20221140, 20221364, 20221746, 20221894, 20222365

UPC codes

08719214223458

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.