FDA-Device2018-07-04Class II

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

Exsurco Medical
Hazard

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.

Sold states
CA, GA, MO, OH & TX
Affected count
70 coaxial hoses
Manufactured in
10804 Green Rd, Wakeman, OH, United States
Products
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2018

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