Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Reason: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Code information: Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.