Device product
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Z-1592-2023
Product summary
- Event
- Event 92072
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1300 units
- Official record key
device-enforcement:Z-1592-2023
Official wording
Reason: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Code information: GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.