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 ophthal
Check against the official notice below — it lists the full affected range.
Beaver Visitec is recalling approximately 800 units of its Accu-Temp High Temperature Cautery (Model 8445000, Lot 6002809) due to a manufacturing defect. A small number of devices in this lot may have a melted cap and a hole formed through the packaging, which could compromise the sterility of the product and potentially cause harm to patients. The affected devices were distributed worldwide, including across multiple U.S. states (California, DC, Florida, Iowa, Idaho, Illinois, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, and Washington) and several countries (Australia, France, Netherlands, Spain, and United Kingdom).
The recall notice does not specify a remedy or instructions for consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom. Quantity: 800 units Lot/code info: Lot 6002809, UDI 8445000 30886158010297
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.