Recall Z-2391-2016— Halyard Health, Inc

Name: FDA recall Z-2391-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-16

Class II · Terminated

Class II FDA medical device recall by Halyard Health, Inc, initiated 2016-06-16, terminated 2016-09-08. It names one FDA 510(k) clearance: K053082. 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.. Reason: Mismatch between the length of the RF electrode (probe) and the cannula (introducer),.

Recalling firm: Halyard Health, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-06-16
Terminated: 2016-09-08
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K053082 — BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6Baylis Medical Co., Inc.·cleared 2005-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.