Device product
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Z-2180-2026
Product summary
- Event
- Event 98708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2180-2026
Official wording
Reason: Incomplete seals on sterile product
Code information: UDI 00885825003890, Lot Numbers: 4064760, 4336810, 4381356, 4381359, 4401919.
Distribution pattern: US Nationwide and the countries of Israel and Canada.
Derived failure modes
-
Unknown
Incomplete seals on sterile product