MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Check against the official notice below — it lists the full affected range.
Datascope Corporation is recalling 10,427 units of its MEGA 8Fr 50cc Intra-Aortic Balloon Catheter across certain lots due to an undersized dilator. The affected products were distributed to 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, and the United Kingdom. Domestic distribution in the United States was pending at the time of the recall.
The affected lots can be identified by their UDI-DI and lot numbers, which include: UDI-DI 10607567109619 (Lot 3000184437), UDI-DI 10607567107301 (Lots 3000171501, 3000183312, 3000183313, 3000186654, and 3000186655). The source does not specify a remedy or what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Certain lots containing undersized dilator.
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.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.