Reported Oct 23, 2019 · Terminated
Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
Xodus Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Xodus Medical Inc · 702 Prominence Dr · New Kensington, PA · 15068-7052
Is this the product you have?
- Electrosurgical Tip Cleaner REF62-8499-001
- Product Usageelectrosurgical accessory
- Lot codes and dates
- Lot #
16DEC1917JAN0617FEB1017MAR2717OCT0917OCT09A17OCT2317OCT23A18JAN0518JAN05A18JAN1918MAR0218MAR1918MAR19A
- UDICase 20787551000584 and Each - 00787551000580
- Additional lots as of 6/8/20
18APR0918MAY0118MAY1118MAY2518MAY25A18MAY25B18JUN2718AUG1418SEP1218OCT03
- Additional lots as of 9/9/202118DEC05 18DEC26 18DEC26A 19JAN30 19JAN30A
- Lot #
- Amount recalled
- 460,000 eaches
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The sterile barrier of some devices may have been affected
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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