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
- Recall Initiated
- March 17, 2023
- Posted
- May 2, 2023
- Recall Number
- Z-1497-2023
- Quantity
- 501 (USA)
- Firm Location
- City Point Waltham, MA
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.
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
Root Cause
Under Investigation by firm
Action Taken
Beaver Visitec in conjuction with (Vitreq B.V.) issued Urgent Medical Device Recall letter CryoTreq REF# CT00.D01-Voluntary recall of affected lots, on 3/17/23 via Certified Mail. Letter states reason for recall, health risk and action to take: 1. Stop using any CryoTreq IMMEDIATELY. Examine your inventory and quarantine product from all lots subject to this voluntary recall. 2. If you have further distributed this product, please identify your customers and notify them of this voluntary product recall. Consider all potential users of this product in your user supply chain. Please provide them with a copy of the present Field Safety Notice. 3. Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit your account OR complete the response form even if you do not have product to return. 4. Return the Attachment 1: Response Form by e-mail to: beavervisitec4599@sedgwick.com 6. Return ALL quarantined product from the affected lots to our company via pre-paid postal labels, which will be supplied to you by our recall team. If you need further assistance, you can contact us using the information below. Email: beavervisitec4599@sedgwick.com Phone: 877-870-4486 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please include in the subject line: Master Case PIR 00424262. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com