Recall Z-2426-2018
Stryker Sustainability Solutions · initiated March 29, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Codes / lots: 2669978 2669987 2688793 2688794 2611427 2683820 2715724 2715729 2715730 2715757 2717434 2717435 2540303 2540308 2669971 2676061 2676062 2676063 2676066 2718603 2718604 2520710 2579520 2597159 2676070 2455042 2698584 2698585 2708150 2708152 2683539 2728373 2728374 2728471 2728473 2698582 2650600 2671503 2673627 2673753 2676052 2723516 2719375 2728372 2667503 2667504 2667508 2711911 2711913 2714099 2634425 2667502 2463266 2711909 2718456 2718457 2727804 2718454 2718455 2653972 2657505 2660189 2662668 2669911 2669912 2669913 2677027 2677030 2677032 2711065 2711067 2717567 2717568 2717569 2718453 2452247 2563722 2627797 2231657 2650352 2652204 2428771 2431261 2455437 2718392 2487373 2492934 2492935 2492936 2530007 2573328 2575113 2577649 2599284 2632405 2632435 2637254 2641646 2642451 2648809 2455438 2455439 2636330 2645840 2649865 2663765 2663767 2673768 2676056 2676060 2676064 2717822 2711322 2711323 2711324 2711325 2711326 2711096 2711100 2711320 2711059 2711062 2421530 2590901 2629625 2630695 2635829 2728880 2711094 2707509 2707514 2707515 2707516 2444646 2444649 2444650 2594332 2609784 2613319 2613320 2625109 2641491 2641725 2644024 2644025 2708370 2708371 2710839 2728685…
Reason for recall
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
FDA-determined cause: Use error
Action taken
The recalling firm issued a notification letter to their sales representatives via email on 3/29/2018 with a response form. For customers who did not return the response form, their will be a subsequent email or fax to their sales rep. The company will continue to follow up via phone and email as needed. The letter identified the affected product, problem and actions to be taken.
Details
- Recall number
- Z-2426-2018
- Initiated
- March 29, 2018
- Terminated
- July 28, 2020
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Quantity
- 2,722 units
- Distribution
- Worldwide Distribution - US Nationwide and Canada
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ