Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Check against the official notice below — it lists the full affected range.
Datascope Corporation has recalled certain lots of an Insertion Kit designed for use with the SENSATION PLUS 8F 50cc Intra-Aortic Balloon Catheter due to undersized dilators in the kits. The recall affects 10,427 units distributed in 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. The affected products are identified by three specific lot numbers: 3000170709, 3000182611, and 3000202083, all with the finished goods part number 0884-00-0019-23.
The source document does not specify a remedy or what actions 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.": 10607567108599, 3000170709, 0884-00-0019-23; 10607567108599, 3000182611, 0884-00-0019-23; 10607567108599, 3000202083, 0884-00-0019-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.