Recall Z-2581-2010 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cardima Inc
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
| Date | Sep 27, 2010 (initiated May 20, 2010) |
| Status | Terminated |
| Reason | Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. |
| Root cause | Device Design |
| Action | Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available. Cardima Customer Service can be contacted at 800 354-0102. |
| Quantity | 28 units |
| Distribution | Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands. |
| FDA record | Open on fda.gov |