FDA recall Z-2204-2021

Product

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

Reason for recall

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Distribution

The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.

Key facts

Status

Terminated

Initiation date

2021-02-25

Report date

2021-08-18

Termination date

2024-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2204-2021