Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Check against the official notice below — it lists the full affected range.
Xodus Medical Inc. is recalling approximately 255,000 Cautery Tip Cleaner devices (model REF: 30500), an electrosurgical accessory, due to potential compromise of the sterile barrier in some units. The affected devices were distributed worldwide, including in the United States in California, Idaho, Illinois, Louisiana, Maryland, New York, Ohio, Oklahoma, Texas, Virginia, and Wisconsin, as well as internationally in Malaysia, Kuwait, Australia, Canada, the United Arab Emirates, Ireland, Korea, Saudi Arabia, Japan, and Mexico.
The recall affects devices from multiple production lots manufactured between December 2016 and March 2019. The source document does not specify a remedy or recommended action for consumers who may have affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
The sterile barrier of some devices may have been affected
Reason for recall: The sterile barrier of some devices may have been affected Distribution: Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico Quantity: 255,000 each Lot/code info: Lot # 16DEC19 17JAN06 17JAN06A 17JAN23 17FEB27 17MAR13 17MAR13A 17APR03 17APR14 17MAY24 17MAY24A 17MAY24B 17JUN27 17JUL17 17AUG01 17SEP22 17SEP22A 17OCT23 17NOV27 17NOV27A 17DEC15 18JAN19 18JAN19A 18FEB16 18MAR02 18MAR19 18MAR19A ***Updated 11/9/21*** 19MAR14 UDI: Case 20787551000577 and Each 00787551000573
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.