Recall Z-2391-2016 ยท GXI Probe, Radiofrequency Lesion
Halyard Health, Inc
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
| Date | Jun 16, 2016 |
| Status | Terminated |
| Reason | Mismatch between the length of the RF electrode (probe) and the cannula (introducer), |
| 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 | 51 kits |
| Distribution | Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 Baylis Medical Co., Inc., Nov 30, 2005 |