Reported Apr 19, 2017 · Terminated
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000…
ConMed Corporation
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: ConMed Corporation · 525 French Rd · Utica, NY · 13502-5945
Is this the product you have?
- Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.
- Lot codes and dates
- Serial Numbers16452971,
868 of 868 codes
1618320160201021607049216110883161712791623166616382087164024851644288416493284161833016020103160704931611088416171280162316671638208816412486164428851649328513181360160201041607049416110885161712811623166816382089164124871644288616493286150100131602010516070495161208861617128216231669163820901641248816442887164932871507043416020106160704961612088716171283162316701638209116412489164428881649328815221592160201071607049716120888161712841623167116382092164124901644288916493289
2,595 of 2,595 codes
165033731540139916040188160805791612097016181365162517731638217416412572164529721650337415401400160401891608058016120971161813661625177416382175164125731645297316503375154014011604019016080581161209721618136716251775163821761641257416452974165033761540140216040191160805821612097316181368162517761638217716412575164529751650337715401403160401921608058316120974161813691625177716382178164125761645297616503378154014041604019316080584161209751618137016251778163821791641257716452977
- Serial Numbers
- Amount recalled
- N/A
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
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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