MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Reason: There is discrepant labeling on the inner and outer packaging of the device.

Code information: UDI-DI: 10607567107974; Lot Number: 3000344298

Distribution pattern: International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.