Z-0171-2020Class II

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

Name: Z-0171-2020 Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump
Creator: ICU Medical Inc
Published: 2018-08-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-08-01 / Terminated / root cause: software

FDA source

ICU Medical Inc began a recall of Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump on 2018-08-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0171-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Posted: 2019-10-22
Terminated: 2021-04-27
Recalling firm: Abbott Medical
Product: Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 8/1/2018 a "Urgent Medical Device Correction" letter was mailed to consignees via traceable mailing. The medical device correction letter informed consignees of the following: 1. To reduce the likelihood of the issue occurring at the bedside, you can consider not utilizing the option to "Force Pump to Accept Drug Library During Power Down" when finalizing the CDL with MedNet. In doing so, when powering down the infuser the clinician will have the option to install the CDL or not, based on the clinical situation. 2. ICU Medical will release a software update to correct the issue and will contact you when the update is available. 3. . Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular 4.Please inform potential users in your organization of this notification, complete the attached response form and return it to the fax number (1-888-628-6849 or e-mail address ([email protected]) on the form, even if you do not have the affected product. 5. For further inquiries, please contact ICU Medical using the information provided below: Global Complaint Management - 1-844-654-7780 or [email protected] Technical Support Center - 1-800-241-4002, option 4 or [email protected]
Quantity in commerce: 47,152 devices
Distribution: US nationwide distribution, and Canada
Product codes and lots: All Plum 360 Infusers with software versions 15.10.00.010/.011/.012 and 15.11.00.017 when used with an ICU Medical MedNet CDL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0171-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0171-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)