FDA-Device2015-01-07Class II
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
PEROUSE MEDICAL
Hazard
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Sold states
US Nationwide Distribution in the states of AZ and CO.
Affected count
24821 units
Manufactured in
ROUTE DU MANOIR, N/A, Ivry Le Temple, N/A, France
Products
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0876-2015Don't want to check this manually?
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