Device product
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Z-1686-2022
Product summary
- Event
- Event 90684
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,427 units
- Official record key
device-enforcement:Z-1686-2022
Official wording
Reason: Certain lots containing undersized dilator.
Code information: Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108605, 3000168086, 0684-00-0576-01; 10607567108605, 3000217952, 0684-00-0576-01; 10607567109633, 3000166607, 0684-00-0576-01U; 10607567109633, 3000169722, 0684-00-0576-01U; 10607567109633, 3000172352, 0684-00-0576-01U; 10607567109633, 3000172353, 0684-00-0576-01U; 10607567109633, 3000176574, 0684-00-0576-01U; 10607567109633, 3000176633, 0684-00-0576-01U; 10607567109633, 3000185680, 0684-00-0576-01U; 10607567109633, 3000196023, 0684-00-0576-01U; 10607567109633, 3000199196, 0684-00-0576-01U; 10607567109633, 3000199197, 0684-00-0576-01U; 10607567109633, 3000199198, 0684-00-0576-01U; 10607567109633, 3000200147, 0684-00-0576-01U; 10607567109633, 3000213850, 0684-00-0576-01U
Distribution pattern: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Derived failure modes
-
Unknown
Certain lots containing undersized dilator.