Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list numb

FDA device recall Z-1599-2011 · posted 2011-03-08 · Terminated

Recall details

Recalling firm

Hospira Inc.

Reason for recall

Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.

Action taken

Hospira sent Urgent Device Recall letters dated February 14, 2011 to their customers on the same date, informing them that Hospira had received complaints of the Plum XL, XLM and XLD infusion pumps in which the audible alarm failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. 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. They were also instructed to ensure that all personnel in their facility are following Hospira's Technical Service Manual for routine decontamination of the pumps and cleaning of the buzzers during preventative maintenance, including inspection of the buzzers for leg lifting. 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 1-866-382-4228.

Root cause

Labeling design

Status

Terminated

Product code

FRN

Quantity affected

145,963 pumps

Distribution

Worldwide distribution, including United States, the U.S. Virgin Islands, Puerto Rico, Argentina, Australia, Bahamas, Bahrain, Barbados, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colomb

Date initiated

2011-02-14

Date posted

2011-03-08

Date terminated

2016-11-07

Location

Lake Forest, IL

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