Reported Dec 2, 2020 · Terminated
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use,…
Medtronic Ats Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDTRONIC ATS MEDICAL, INC. · 3800 Annapolis Ln N · Plymouth, MN · 55447-5439
Is this the product you have?
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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.
- Lot codes and dates
- Model Number 60SF3
- GTIN 00763000114626 Serial Numbers
174200001742000117420002174200031742000417420005174200061742000717420008174200091742001017420013174200141742001517420016174200171742001817420019174200201742002217420023174200241742002517420026174200271742002817420029184200001842000118420002184200031842000418420015184200161842002118420022184200231842002418420025184200261842002719820016198200171982001819820019198200201982002119820022198200231982002421020005223200382232004022320041223200422232004322320044
- Amount recalled
- 57 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
This product could cause temporary or reversible health problems — stop using it.
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