FDA-Device2024-11-13Class II
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Datascope Corp.
Hazard
There is discrepant labeling on the inner and outer packaging of the device.
Sold states
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
Affected count
160 units
Manufactured in
15 Law Dr Unit 1, N/A, Fairfield, NJ, United States
Products
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0311-2025Don't want to check this manually?
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