Recall Z-2678-2017— ICU

Name: FDA recall Z-2678-2017
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Class II · Terminated

Class II FDA medical device recall by ICU, initiated 2013-02-01, terminated 2018-05-31. It names one FDA 510(k) clearance: K070398. 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: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues..

Recalling firm: ICU
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Terminated: 2018-05-31
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K070398 — HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391Hospira, Inc.·cleared 2007-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.