Recall Z-1497-2023 ยท HPS Unit, Cryophthalmic
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
| Date | May 2, 2023 (initiated Mar 17, 2023) |
| Status | Open, Classified |
| 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 t |
| Quantity | 501 (USA) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202038 | CryoTreQ VitreQ BV, Dec 30, 2020 |