FDA recall Z-2291-2018

Product

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

Reason for recall

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.

Distribution

CA, GA, MO, OH & TX

Key facts

Status

Terminated

Initiation date

2018-04-17

Report date

2018-07-04

Termination date

2020-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wakeman, OH, United States

Primary source

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