Z-3031-2017Class II

Plum 360 Infusion System

Name: Z-3031-2017 Plum 360 Infusion System
Creator: ICU Medical Inc
Published: 2017-06-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-06-15 / Terminated

FDA source

ICU Medical Inc began a recall of Plum 360 Infusion System on 2017-06-15. FDA classified it as Class II and gives the reason as "Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3031-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Posted: 2017-08-14
Terminated: 2020-04-17
Recalling firm: Abbott Medical
Product: Plum 360 Infusion System
Product code: FRN Pump, Infusion
Reason for recall: Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
FDA root cause: Under Investigation by firm
Action: ICU Medical sent an Urgent - Medical Device Correction letter dated June 15, 2017, to all affected customers. The firm contracted with Stericycle for recall notification, response tracking, and effectiveness checks. The customer notification was also posted on icumed.com. The notification requested that consignees verify their unit is working and testing the CE Module. If the unit's CE Module is loose or a blank display occurs, customers are asked to record the S/N and contact ICU Medical Technical Service Support Center at 800-241-4002, option 4. If the unit is functional, return to service. If the unit powers down without an alarm notification, use another unit and contact ICU Medical Global Complaint Management at 800-441-4100. The firm will contact reporting consignees of correction scheduling when parts become available. Adverse reactions or quality problems related to this problem should be reported to FDA's MedWatch Adverse Event Reporting Program by mail, fax, or online. Consignees are advised to inform potential users within their organization of the recall and to complete the recall response form attached to recall notification. The completed response form can be returned by email to [email protected] or faxed to 855-544-4814. If product was distributed, ask customers to request them to contact Stericycle for a copy of recall notification at 855-544-4813.
Quantity in commerce: 68,559 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: Model No. 30010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3031-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3031-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-14

Product code FRN

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)