FDA Medical Device Recalls (openFDA)
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 to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
- Recall number
- Z-1497-2023
- Recalling firm
- Beaver Visitec International, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2023-03-17
- Posted
- 2023-05-02
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 501 (USA)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K202038"]
- PMA numbers
- not on file
- Product code
- HPS
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28