Recall Z-1452-06 ยท LPB Cardiac Ablation Percutaneous Catheter
CryoCath Technologies Inc.
7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
| Date | Aug 29, 2006 (initiated Aug 4, 2006) |
| Status | Terminated |
| Reason | Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1. |
| Root cause | Other |
| Action | Consignees were notified by letter on 08/04/2006. |
| Quantity | 34 units |
| Distribution | Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.