Reported May 10, 2023 · Ongoing
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures…
Beaver Visitec International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beaver Visitec International, Inc. · 500 Totten Pond Rd · Waltham, MA · 02451-1916
Is this the product you have?
- 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
- RefCT00.D01
- Lot codes and dates
- GTIN08719214223458
- All Affected Lots
202144502021436620214367202145182021452220214615202147442021474520214961202149622021520320215204202154792021626320216264202160102022795220227950202279512022840820228657202288972022889820229034202291382022933420229460202296302022974820230261202210832022114020221364202217462022189420222365
- Amount recalled
- 501 (USA)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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