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

FDA device recall Z-1646-2011 · posted 2011-03-14 · Terminated

Recall details

Recalling firm

Hospira Inc.

Reason for recall

Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.

Action taken

The firm, Hospira, sent "URGENT DEVICE RECALL" letters dated February 14, 2011 to their customers on the same date. The letter described the product, problem and action to be taken by the customers. The Customer/Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-888-216-7330.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Quantity affected

98 pumps

Distribution

Worldwide distribution: United States including the U.S. Virgin Islands and Puerto Rico, and countries including: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cos

Date initiated

2011-02-14

Date posted

2011-03-14

Date terminated

2016-11-08

Location

Lake Forest, IL

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