FDAFDA · Food and drugs·Recall number Z-2391-2016
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Published August 17, 2016 · Recall initiated: June 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Halyard Health, Inc
- Distributor
- Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
- Lot
- Lot Number M5264D205
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.