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Recall Observatory FDA recall evidence

Device product

Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory

Z-0149-2020

September 19, 2019

Class II

Product summary

Firm
Xodus Medical Inc
Event
Event 83819
Status
Terminated
Classification
Class II
Quantity
464,040 eaches
Official record key
device-enforcement:Z-0149-2020

Official wording

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

Code information: 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

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