Device product
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Z-2911-2016
Product summary
- Event
- Event 75014
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,425 catheters
- Official record key
device-enforcement:Z-2911-2016
Official wording
Reason: Arrow is recalling due to incorrect labeling of products.
Code information: Lot/Batch 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347. CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, 14F15G0348
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Labeling or packaging
incorrect labeling