FDA recall Z-0171-2020

Product

Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

Reason for recall

A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.

Distribution

US nationwide distribution, and Canada

Key facts

Status

Terminated

Initiation date

2018-08-01

Report date

2019-10-30

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2020