[Recalled] Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small v
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include opht |
|---|---|
| Brand / manufacturer | Beaver Visitec |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-3045-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 July 2018 |
| EAN / barcode | 30886158010297 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Beaver Visitec
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.