Device product
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Z-2189-2026
Product summary
- Event
- Event 98708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-2189-2026
Official wording
Reason: Incomplete seals on sterile product
Code information: UDI 00885825006969, Lot Numbers: 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, 4720693.
Distribution pattern: US Nationwide and the countries of Israel and Canada.
Derived failure modes
-
Unknown
Incomplete seals on sterile product