Device 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.
Z-3045-2018
Product summary
- Firm
- Beaver Visitec
- Event
- Event 80846
- Status
- Terminated
- Classification
- Class II
- Quantity
- 800 units
- Official record key
device-enforcement:Z-3045-2018
Official wording
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.
Code information: Lot 6002809, UDI 8445000 30886158010297
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.