Beaver Visitec recalls CryoTreQ-Aa disposable handheld ophthalmic surgery devices that may suddenly disassemble during cryotherapy, potentially causing permanent injury. Affected lots listed in the 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.
Beaver Visitec recalls CryoTreQ-Aa disposable handheld instruments used in eye surgery that can suddenly and forcefully disassemble during procedures, risking permanent injury to patients or users. This recall affects specific production lots sold between 2021 and 2023.
The device uses cryogenic temperatures to freeze tissue during surgery. If it suddenly or forcefully disassembles during use, it could cause permanent damage to the patient's or user's eye or surrounding structures.
Ophthalmic surgeons and medical professionals who use the CryoTreQ-Aa device for eye surgery are most at risk. Patients undergoing procedures with this device could also face injury if the device disassembles unexpectedly.
Check for the product name 'CryoTreQ-Aa' on the device. Affected lots include specific numbers listed in the recall (e.g., 20214450, 20214366, etc.) sold between 2021 and 2023.
Look for the lot number on the device packaging or label to see if it matches the affected lots listed in the recall.
Reach out to Beaver Visitec International, Inc. for guidance on next steps if your device is affected.
The device has a risk of sudden disassembly during surgery, which could cause permanent injury. It is not safe to use without checking if it's in an affected lot.
Check the lot number against the affected lots listed in the recall. If it matches, contact Beaver Visitec International, Inc. for further instructions.
Look for the product name 'CryoTreQ-Aa' and check the lot number against the specific affected lots listed in the recall (e.g., 20214450, 20214366, etc.).
We’ve drafted a message you can send Beaver Visitec to request your refund or repair — edit it as you like.
Subject: Recall Z-1497-2023 — Beaver Visitec Beaver Visitec Hello, I own a Beaver Visitec that is covered by recall Z-1497-2023 from Beaver Visitec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.