Recall Z-2478-2015 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Abbott Electrophysiology
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
| Date | Aug 28, 2015 (initiated Aug 12, 2015) |
| Status | Terminated |
| Reason | The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge. If you have any questions, contact Quality Director at 650-681-1744. |
| Quantity | 86 units |
| Distribution | US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130827 | FIRMAP CATHETER Topera, Inc., Oct 31, 2013 |