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Class 2 Device Recall Plum A Infusion Pump, Single Channel |
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Date Initiated by Firm |
February 06, 2013 |
Date Posted |
September 06, 2016 |
Recall Status1 |
Terminated 3 on November 14, 2016 |
Recall Number |
Z-2724-2016 |
Recall Event ID |
64261 |
510(K)Number |
K081412
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Product Classification |
Pump, infusion - Product Code FRN
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Product |
Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose 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. |
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 |
Hospira Inc. 275 N Field Dr Lake Forest IL 60045-2579
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For Additional Information Contact |
Chris Eustace 224-212-2000
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Manufacturer Reason for Recall |
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field. |
Quantity in Commerce |
357,778 total |
Distribution |
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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