Recall Z-3045-2018— Beaver Visitec

Name: FDA recall Z-3045-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-19

Class II · Terminated

Class II FDA medical device recall by Beaver Visitec, initiated 2018-07-19, terminated 2019-05-23. It names one FDA 510(k) clearance: K771189. 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..

Recalling firm: Beaver Visitec
Classification: Class II
Status: Terminated
Initiated: 2018-07-19
Terminated: 2019-05-23
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K771189 — HOT TEMP CAUTERYEdward Weck, Inc.·cleared 1977-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.