FDA-Device2022-09-14Class II
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Datascope Corporation
Hazard
Certain lots containing undersized dilator.
Sold states
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.
Affected count
10,427 units
Manufactured in
15 Law Dr, N/A, Fairfield, NJ, United States
Products
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2022Don't want to check this manually?
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