FDA Device recall Z-3045-2018
Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use…
- FDA Device
- Class II
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class II recall of Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use… by Beaver Visitec, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3045-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-19 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beaver Visitec |
| Distribution | US |
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 ophthalmic, general and plastic surgery.
Reason
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.
Identifiers
| code_info | Lot 6002809, UDI 8445000 30886158010297 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3045-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.