Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT,
FDA device recall Z-0340-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Stryker Sustainability Solutions
- Reason for recall
- Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NLH
- Quantity affected
- 46 units total
- Distribution
- US Distribution: in the states of: Arizona, California, and Ohio.
- Date initiated
- 2013-10-18
- Date posted
- 2013-11-18
- Date terminated
- 2013-12-06
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030187) | Alliance Medical, Inc. | 2003-09-24 |
| ELECTROPHYSIOLOGY CATHETER (K030109) | Alliance Medical Corp. | 2003-08-08 |
| ELECTROPHYSIOLOGY CATHETER (K012708) | Alliance Medical Corp. | 2002-08-13 |