Coolife Sinergy Radiofrequency Kit recall
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions…
Why was Coolife Sinergy Radiofrequency Kit recalled?
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number M5264D205
- Product
- Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions…
- Recalling firm
- Halyard Health, Inc
- Quantity
- 51 kits
- Distribution
- Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
- Recall date
- August 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)