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U.S. Department of Health and Human Services

Class 2 Device Recall Plum A SIngle Channel Infusion Pumps

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  Class 2 Device Recall Plum A SIngle Channel Infusion Pumps see related information
Date Initiated by Firm February 14, 2011
Date Posted March 14, 2011
Recall Status1 Terminated 3 on November 08, 2016
Recall Number Z-1644-2011
Recall Event ID 57724
510(K)Number K011442  K982159  K070398  K042081  
Product Classification Pump, infusion - Product Code FRN
Product Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations:
a) list 11971
b) list 11973 - software version 10.3
c) list 12391 - software version 11.3
d) list 20679 - Hospira MedNet Software
e) list 20792 - Driver

The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield¿ needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system.
Code Information a) list 11971- serial numbers 0013120009 through 0099072443;  b) list 11973 - serial numbers 0012570148 through 0012579183;  c) list 12391 - serial numbers 0013840001 through 0013890171;  d) list 20679 - serial numbers 0015441019 through 0015459165;  e) list 20792 - serial numbers 0016061001 through 0018787700 
Recalling Firm/
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Ms. Ileana Quinones
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 144,477 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, Costa Rica, Denmark, Dominican Republic, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, United Arab Emirates and Vietnam.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES
510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.