PEROUSE MEDICAL recalls Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create…

Recall date

October 6, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0876-2015

FDA classification

Class II

Brand / firm

PEROUSE MEDICAL

Sold / distributed

US Nationwide Distribution in the states of AZ and CO.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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