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Recall Observatory FDA recall evidence

Device product

Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.

Z-2391-2016

June 16, 2016

Class II

Product summary

Firm
Halyard Health, Inc
Event
Event 74553
Status
Terminated
Classification
Class II
Quantity
51 kits
Official record key
device-enforcement:Z-2391-2016

Official wording

Reason: Mismatch between the length of the RF electrode (probe) and the cannula (introducer),

Code information: Lot Number M5264D205

Distribution pattern: Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mismatch between the length of the RF electrode (probe) and the cannula (introducer),