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U.S. Department of Health and Human Services

Class 2 Device Recall Plum A Infusion Pump

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 Class 2 Device Recall Plum A Infusion Pumpsee related information
Date Initiated by FirmFebruary 01, 2013
Date PostedJuly 07, 2017
Recall Status1 Terminated 3 on May 31, 2018
Recall NumberZ-2677-2017
Recall Event ID 64542
510(K)NumberK070398 
Product Classification Pump, infusion - Product Code FRN
ProductThe Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.
Code Information List number: 11973 Serial Numbers 12570148 12570150 12570154 12570163 12570170 12570177 12570204 12570211 12570212 12570255 12570270 12570319 12570359 12570385 12570413 12570425 12570455 12570487 12570662 12570695 12570854 12570915 12571080 12571243 12571437 12571631 12571692 12571776 12571826 12571835 12571837 12571842 12571877 12571880 12571886 12572317 12572369 12572586 12572909 12573547 12573567 12573837 12573990 12574424 12574501 12574524 12574556 12574599 12574619 12574731 12574749 12574853 12574858 12574860 12574865 12574961 12575626 12575698 12575886 12576125 12576443 12576485 12576518 12576593 12576609 12576710 12576722 12577271 12577685 12578856 12579183 
Recalling Firm/
Manufacturer		 ICU
600 N Field Dr
Lake Forest IL 60045-4835
Manufacturer Reason
for Recall		A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
FDA Determined
Cause 2		Other
ActionHospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
Quantity in Commerce71 units
DistributionNationwide, Worldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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