Exsurco Medical recalls Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

Recall date

April 17, 2018

Source

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

Recall number

Z-2291-2018

FDA classification

Class II

Brand / firm

Exsurco Medical

Sold / distributed

CA, GA, MO, OH & TX

Why it was recalled

Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.

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

What was recalled

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004