Reported Aug 17, 2016 · Terminated
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to…
Halyard Health, 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: Halyard Health, Inc · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894
Is this the product you have?
- Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
- Lot codes and dates
- Lot Number M5264D205
- Amount recalled
- 51 kits
Where it was sold
Why it was recalled
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
This product could cause temporary or reversible health problems — stop using it.
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