Z-1702-2014Class II

LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids...

Name: Z-1702-2014 LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids...
Creator: Hospira Inc.
Published: 2014-01-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-01-24 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration on 2014-01-24. FDA classified it as Class II and gives the reason as "There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1702-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Posted: 2014-06-03
Terminated: 2016-11-07
Recalling firm: Abbott Medical
Product: LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Product code: FRN Pump, Infusion
Reason for recall: There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
Root cause tag: design
FDA root cause: Component design/selection
Action: Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 24, 2014, to all affected customers via traceable UPS. The letters included instructions for recipients to: inspect the door roller assemblies; if a door roller or pin appears loose, broken or missing, remove the device from clinical service until the door assembly is replaced with a corrected door assembly and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. All devices requiring repair will be serviced and replaced with the existing design door and/or pin. Hospira is in the process of designing a metal door roller pin to replace the plastic on currently available on the Plum XL and once that design is complete, any door roller/pin serviced on a Plum XL will be replaced with the new metal design. Recipients are further instructed to: inform potential users in their organization of the recall notification; complete the attached reply form and return it to the fax number or e-mail address on the form; and if the pumps were further distributed, to notify the accounts that received the devices and ask them to contact Stericycle at 877-597-9581 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. The URGENT MEDICAL DEVICE RECALL letter also reports that Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL families of infusion devices as noted in the IMPORTANT PLUM INFUSION PUMP DISCONTINUATION AND TRANSITION NOTICE issued May 1, 2013. As of June 30, 2015, Hospira will consider the products within the Plum LifeCare 5000 and Plum XL Infusion Systems families retired and will no longer support them. For questions regarding this recall call 224-212-2000.
Quantity in commerce: List Number 02507: 132,889 pumps
Distribution: Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
Product codes and lots: List Number: 02507; Serial Numbers: All.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1702-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03
Z-1703-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03
Z-1704-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03

Product code FRN

K911401Class IIAbbott Lifecare 5000 PumpAbbott Laboratories / cleared 1991-05-28

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)