Beaver Visitec recalls specific cautery devices due to potential melted packaging causing contamination. Affected units may not be sterile, risking patient harm during surgery.
A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
Beaver Visitec is recalling a specific model of surgical cautery device because a small number of units may have melted packaging that could compromise sterility. This poses a risk of infection or harm to patients during surgery.
The melted packaging could allow contaminants to enter the device, making it non-sterile. This could lead to infections or other complications during surgical procedures if the device is used without proper sterility.
Surgical professionals using the Beaver Accu-Temp High Temperature Cautery (Model 8445000) for procedures like ophthalmic or plastic surgery. Patients undergoing these procedures are at risk if the device is not sterile.
Check for the model number 8445000 on the device. The affected units were sold with lot number 6002809 and UDI 8445000 30886158010297.
Look for the model number 8445000 and lot number 6002809 on the device packaging.
The recall states that a small number of devices may have melted packaging that could compromise sterility, so it is not safe to use without checking the model number and lot number.
Check for the model number 8445000 and lot number 6002809 on the device packaging.
The recall does not specify a remedy, so you should check the device packaging for the model and lot numbers to determine if it is affected.
We’ve drafted a message you can send Beaver Visitec to request your refund or repair — edit it as you like.
Subject: Recall Z-3045-2018 — Beaver Visitec Beaver Visitec Hello, I own a Beaver Visitec that is covered by recall Z-3045-2018 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.
