Datascope Corporation: Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

Is my product affected?

Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

• UPC 10607567108605
• UPC 10607567109633

Check against the official notice below — it lists the full affected range.

What happened

Datascope Corporation is recalling 10,427 units of its Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter due to certain lots containing an undersized dilator. The affected product was distributed to multiple countries including Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom, and others. The recalled units are identified by specific lot numbers and UDI codes listed in the recall notice.

Consumers who have received this product should check whether their catheter matches any of the lot numbers and UDI codes specified in the recall. The source document does not specify a remedy or instructional action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Certain lots containing undersized dilator.

Details from the source

Reason for recall: Certain lots containing undersized dilator. 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. Quantity: 10,427 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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