Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- MEDTRONIC ATS MEDICAL, INC.
- Reason for Recall:
- There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 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.
Product Codes/Lot Numbers:
Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0495-2021
Related Recalls
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices