FDA recall Z-1651-2021

Product

Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

Reason for recall

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Distribution

Us distribution to the states of IN and TX.

Key facts

Status

Ongoing

Initiation date

2021-03-25

Report date

2021-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clarksville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2021