Z-1497-2023 Class II Ongoing
FDA device recall Z-1497-2023 was initiated by Beaver Visitec International, Inc. on March 17, 2023 and is designated Class II. 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 cr… The recall status is ongoing. Affected quantity: 501 (USA).
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- March 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 501 (USA)
Product Description
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
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 Pattern
US Nationwide distribution.
Code Information
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