Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter recall
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Why was Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter recalled?
Certain lots containing undersized dilator.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
- Recalling firm
- Datascope Corporation
- Quantity
- 10,427 units
- Distribution
- 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.
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)