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Halyard Health, Inc recalls Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to
Recalled August 17, 2016 · FDA recall Z-2391-2016 · Halyard Health
Hazard
Mismatch between the length of the RF electrode (probe) and the cannula (introducer), · FDA Class II
Units
51 kits
Sold at
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Description
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
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.
Manufacturer(s)
Halyard Health, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →