Recall Z-0380-2017 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiec
| Date | Oct 6, 2016 |
| Status | Terminated |
| Reason | The EP Catheters may be mislabeled for French size during reprocessing. |
| Root cause | Under Investigation by firm |
| Action | The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tem |
| Quantity | 4 devices |
| Distribution | U.S. distribution to the following; AZ, MN and MO. |
| FDA record | Open on fda.gov |