Device product
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Z-2194-2026
Product summary
- Event
- Event 98708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2194-2026
Official wording
Reason: Incomplete seals on sterile product
Code information: UDI 00885825007294, Lot Numbers: 3293805, 4060170, 4533158, 4613654, 4678077, 4846998, 4973532, 4976226, 5005455, 5056648.
Distribution pattern: US Nationwide and the countries of Israel and Canada.
Derived failure modes
-
Unknown
Incomplete seals on sterile product