FDAFDA · Food and drugs·Recall number Z-0149-2020
Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Published October 23, 2019 · Recall initiated: September 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The sterile barrier of some devices may have been affected
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Xodus Medical Inc
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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