Device product
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Z-2175-2026
Product summary
- Event
- Event 98708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-2175-2026
Official wording
Reason: Incomplete seals on sterile product
Code information: UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.
Distribution pattern: US Nationwide and the countries of Israel and Canada.
Derived failure modes
-
Unknown
Incomplete seals on sterile product