Recall Z-0101-2018— ICU Medical Inc

Name: FDA recall Z-0101-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-30

Class II · Terminated

Class II FDA medical device recall by ICU Medical Inc, initiated 2017-10-30, terminated 2019-08-28. It names one FDA 510(k) clearance: K161469. Product: Plum 360 Infusion System, List number 30010.. Reason: (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled..

Recalling firm: ICU Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-30
Terminated: 2019-08-28
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc.·cleared 2017-03-28

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

Plum 360 Infusion System, List number 30010.

Reason for recall

(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.

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