Z-2391-2016Class II

Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency...

Name: Z-2391-2016 Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency...
Creator: Halyard Health, Inc
Published: 2016-06-16
License: https://open.fda.gov/license/

Halyard Health / initiated 2016-06-16 / Terminated / root cause: manufacturing process

FDA source

Halyard Health, Inc began a recall of Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in... on 2016-06-16. FDA classified it as Class II and gives the reason as "Mismatch between the length of the RF electrode (probe) and the cannula (introducer)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2391-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-16
Posted: 2016-08-11
Terminated: 2016-09-08
Recalling firm: Halyard Health
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.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All distributors and healthcare facilities that were directly shipped recalled devices were notified of the recall beginning 6/16/2016 by email and by FedEx. They were instructed to examine their stock and to quarantine and discontinue use of the product. The letter contained a response form which was to faxed back to Halyard.
Quantity in commerce: 51 kits
Distribution: Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Product codes and lots: Lot Number M5264D205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2391-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2391-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code GXI

K053082Class IIBaylis Pain Management Cooled Probe, Model Pmpc-18-150-6Baylis Medical Co., Inc. / cleared 2005-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)