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Recall Observatory FDA recall evidence

Device product

Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory

Z-0151-2020

September 19, 2019

Class II

Product summary

Firm
Xodus Medical Inc
Event
Event 83819
Status
Terminated
Classification
Class II
Quantity
255,000 each
Official record key
device-enforcement:Z-0151-2020

Official wording

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

Code information: 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

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