Z-0101-2018Class II

Plum 360 Infusion System, List number 30010

Name: Z-0101-2018 Plum 360 Infusion System, List number 30010
Creator: ICU Medical Inc
Published: 2017-10-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-10-30 / Terminated

FDA source

ICU Medical Inc began a recall of Plum 360 Infusion System, List number 30010 on 2017-10-30. FDA classified it as Class II and gives the reason as "(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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0101-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-30
Posted: 2017-11-16
Terminated: 2019-08-28
Recalling firm: Abbott Medical
Product: Plum 360 Infusion System, List number 30010.
Product code: FRN Pump, Infusion
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.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.
Quantity in commerce: 21,461 devices
Distribution: Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
Product codes and lots: All devices with software v15.10.00.010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0101-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0101-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-16

Product code FRN

K161469Class IIPlum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. / cleared 2017-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)