FDAFDA · Food and drugs·Recall number Z-0496-2021
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.
Published December 2, 2020 · Recall initiated: October 12, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDTRONIC ATS MEDICAL, INC.
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
- Lot
- Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.