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Recall Observatory FDA recall evidence

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

July 19, 2018

Class II

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

    reason.no_named_rule · v1.0.0

    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.