Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intra

FDA device recall Z-1703-2014 · posted 2014-06-03 · Terminated

Recall details

Recalling firm

Hospira Inc.

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

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

List Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859: 147,399 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, Ch

Date initiated

2014-01-24

Date posted

2014-06-03

Date terminated

2016-11-07

Location

Lake Forest, IL

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