Skip to content
Recall Observatory FDA recall evidence

Device product

Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory

Z-0150-2020

September 19, 2019

Class II

Product summary

Firm
Xodus Medical Inc
Event
Event 83819
Status
Terminated
Classification
Class II
Quantity
460,000 eaches
Official record key
device-enforcement:Z-0150-2020

Official wording

Reason: The sterile barrier of some devices may have been affected

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sterile barrier of some devices may have been affected