medical Class II Updated 2024-11-13

Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Mode

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
Lot/Code Info: UDI-DI: 10607567107974; Lot Number: 3000344298
View official government recall

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