Electrosurgical Tip Cleaner recall: Sterility Concern
Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
Why was Electrosurgical Tip Cleaner recalled?
The sterile barrier of some devices may have been affected
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
- Recalling firm
- Xodus Medical Inc
- Quantity
- 460,000 eaches
- 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
- Recall date
- October 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)