Halyard Health, Inc recalls Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to…

Recall date

June 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2391-2016

FDA classification

Class II

Brand / firm

Halyard Health, Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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