Device product
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Z-2196-2026
Product summary
- Event
- Event 98708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2196-2026
Official wording
Reason: Incomplete seals on sterile product
Code information: UDI 00885825007331. Lot Numbers: 3557411, 3702628, 4498116.
Distribution pattern: US Nationwide and the countries of Israel and Canada.
Derived failure modes
-
Unknown
Incomplete seals on sterile product