Medical device recalls Moderate risk

PEROUSE MEDICAL recalls DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE…

Recall date
April 5, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1891-2017
FDA classification
Class II
Brand / firm
PEROUSE MEDICAL
Sold / distributed
US: AZ (shipped through Belgium to USA), MN, TN

Why it was recalled

Complaints regarding broken blister.

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

What was recalled

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND

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