Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
Check against the official notice below — it lists the full affected range.
Xodus Medical Inc. is recalling approximately 460,000 Electrosurgical Tip Cleaner devices (Model REF: 62-8499-001) because the sterile barrier of some devices may have been affected. The affected devices were distributed worldwide, including across multiple U.S. states (California, Idaho, Illinois, Louisiana, Maryland, New York, Ohio, Oklahoma, Texas, Virginia, and Wisconsin) and internationally in Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, and Mexico. Multiple lot numbers are involved in this recall, spanning from December 2016 through January 2019.
The recall notice does not specify a remedy or recommended action for consumers who have this product.
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: 460,000 eaches Lot/code info: Lot # 16DEC19 17JAN06 17FEB10 17MAR27 17OCT09 17OCT09A 17OCT23 17OCT23A 18JAN05 18JAN05A 18JAN19 18MAR02 18MAR19 18MAR19A UDI: Case 20787551000584 and Each - 00787551000580 Additional lots as of 6/8/20: 18APR09 18MAY01 18MAY11 18MAY25 18MAY25A 18MAY25B 18JUN27 18AUG14 18SEP12 18OCT03 Additional lots as of 9/9/2021: 18DEC05 18DEC26 18DEC26A 19JAN30 19JAN30A
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.