FDA recall Z-2676-2017

ICU · Class II · device

Product

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

Reason for recall

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Distribution

Nationwide, Worldwide

Key facts

Status
Terminated
Initiation date
2013-02-01
Report date
2017-07-19
Termination date
2018-05-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2676-2017