CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504) recalled
Halyard Health is recalling Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504), distributed in 8 states. The recall was initiated on 16 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2391-2016
- FDA event ID
- 74553
- Recalling firm
- Halyard Health, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2016
- FDA classified
- 11 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jun 2016 | Recall initiated by company | |
| 11 Aug 2016 | Classified by FDA | +56 days |
| 17 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Product as listed by the FDA
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Where it was distributed
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
ConnecticutIllinoisMassachusettsMichiganNorth CarolinaNew HampshireNevadaTexas
Questions about this recall
Why was it recalled?
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Which lots are affected?
Lot Number M5264D205
Where was it sold?
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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