Recall Z-0340-2014 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological map
| Date | Nov 18, 2013 (initiated Oct 18, 2013) |
| Status | Terminated |
| Reason | Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal. |
| Root cause | Process control |
| Action | Stryker sent an Urgent Medical Device Removal Notification letter to affected customers. The letter informed customers of the affected product, problem identified and the actions to be taken. Customers are instructed to complete the "Recall Effectiveness Form" and fax to Moira Barton-Varty, Senior Director Regulatory Affairs at (480) 809-4957. Customers with any serious adverse events or product problems are instructed to call Stryker Sustainability Solutions at (888) 763-8803. |
| Quantity | 46 units total |
| Distribution | US Distribution: in the states of: Arizona, California, and Ohio. |
| FDA record | Open on fda.gov |