Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Check against the official notice below — it lists the full affected range.
Xodus Medical Inc. is recalling its Electrosurgical Tip Cleaner, an electrosurgical accessory, because the sterile barrier of some devices may have been affected. The recall involves 464,040 units 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, the United Arab Emirates, Ireland, Korea, Saudi Arabia, Japan, and Mexico. Multiple lot numbers are affected, spanning from November 2017 through March 2019.
The recall record does not specify a remedy or what affected consumers should do.
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: 464,040 eaches Lot/code info: Lot # 17NOV27 17DEC08 17DEC08A 17DEC15 17DEC15A 18JAN05 18JAN05A 18JAN19 18FEB02 18FEB02A 18FEB16 18MAR02 18MAR19 UDI: Case 20787551000539 and Each - 00787551000535 Additional lots as of 6/8/20: 18JUL27 18JUL27A 18SEP12 18MAY11 18APR09 18OCT03 18MAY01 18NOV21 18NOV21A Additional lots as of 9/9/2021: 18DEC05 19JAN16 19JAN30 19FEB13 19FEB27 19MAR14 19MAR14A 19MAR29
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.