Device product
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Z-2198-2026
Product summary
- Event
- Event 98708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2198-2026
Official wording
Reason: Incomplete seals on sterile product
Code information: UDI 00885825007324, Lot Numbers: 4101996, 4175347.
Distribution pattern: US Nationwide and the countries of Israel and Canada.
Derived failure modes
-
Unknown
Incomplete seals on sterile product