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PEROUSE MEDICAL recalls Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to cr
Recalled January 7, 2015 · FDA recall Z-0876-2015 · 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 · FDA Class II
Units
24821 units
Sold at
US Nationwide Distribution in the states of AZ and CO.
Description
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
Product
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
Manufacturer(s)
PEROUSE MEDICAL
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →