Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Pl

FDA device recall Z-0011-2012 · posted 2011-10-04 · Terminated

Recall details

Recalling firm

Hospira Inc.

Reason for recall

Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting.

Action taken

The firm, Hospira sent "URGENT DEVICE RECALL" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance. *** Follow-up letters dated June 26, 2012 were sent to the accounts listing the device modules with software versions v13.2, v13.3, v13.40 and v13.5 that will require the software upgrade. ***

Root cause

Software design

Status

Terminated

Product code

FRN

Quantity affected

120 pumps

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Ri

Date initiated

2011-09-16

Date posted

2011-10-04

Date terminated

2016-11-07

Location

Lake Forest, IL

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