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.
- Company
- Hospira Inc.
- Recall Initiated
- February 6, 2013
- Posted
- September 6, 2016
- Terminated
- November 14, 2016
- Recall Number
- Z-2724-2016
- Quantity
- 357,778 total
- Firm Location
- Lake Forest, IL
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.
Distribution
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.