Halyard Health, Inc: Medical Device Recall in 2016 - (Recall #: Z-2391-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 16, 2016

Date Posted: August 17, 2016

Recall Number: Z-2391-2016

Event ID: 74553

Reason for Recall:

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

Status: Terminated

Product Quantity: 51 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated