Device product
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Z-1593-2023
Product summary
- Event
- Event 92072
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10833 units
- Official record key
device-enforcement:Z-1593-2023
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 08714729965770 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30319836,30359588,30368418,30392647,30409465,30421836, 30442123,30522919,30564343,30577971,30593836,30600837, 30600839,30601021,30616553,30620297,30625219,30638465, 30638467,30638469,30638471,30665570,30666996,30681966, 30681968,30681970,30712588,30725194,30780665,30801487, 30801489,30801491,30811488,30845828,30845830,30845832, 30885087,30890263,30890265,30914070,30922072,30929565, 30935495,30935497,30935499,30981820
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.