Halyard Health Recalls Coolife Sinergy Radiofrequency Kits Due to Component Mismatch
Halyard Health is recalling 51 Coolife Sinergy Radiofrequency Kits because the electrode length does not match the cannula length.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a medical device used for invasive procedures where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Halyard Health, Inc. is recalling 51 units of the Coolife Sinergy Radiofrequency Kit, model SIK-17-75-4 (109971504). The recall is due to a mismatch between the length of the radiofrequency electrode (probe) and the cannula (introducer). The affected lot number is M5264D205.
These kits are used in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue. The affected units were distributed in the states of Connecticut, Illinois, Massachusetts, Michigan, Nevada, New Hampshire, North Carolina, and Texas, as well as in Canada.
Healthcare providers and consumers should stop using the affected kits and contact Halyard Health for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Halyard Health, Inc
- Affected units
- 51
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number M5264D205
Distribution
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