Z-2391-2016 Class II Terminated
FDA device recall Z-2391-2016 was initiated by Halyard Health, Inc on June 16, 2016 and is designated Class II. Reason for recall: Mismatch between the length of the RF electrode (probe) and the cannula (introducer), The recall status is terminated (terminated September 8, 2016). Affected quantity: 51 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2016
- Initiation Date
- June 16, 2016
- Termination Date
- September 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 kits
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),
Distribution Pattern
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Code Information
Lot Number M5264D205