FDAMarch 17, 2023device
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
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
beaver visitecbeaver
UPCs
08719214223458
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;2024-07-26
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