Recall Z-1708-2016 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
| Date | Apr 28, 2016 |
| Status | Terminated |
| Reason | Mislabeled for size |
| Root cause | Under Investigation by firm |
| Action | The firm sent out customer notification letters on 04/28/16. Customers are instructed to discontinue the use of affected lots of recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to facility is enclosed. Please complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in your inventory. This form needs to be completed even if no affected product is found. Please return the completed and sig |
| Quantity | 18 devices |
| Distribution | Distributed in the state of NY and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012708 | ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp., Aug 13, 2002 |