—#115712

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081412
Affected 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.

Why it was recalled

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.

Timeline

Recall initiated: 2013-02-06
Posted by FDA: 2016-09-06
Terminated: 2016-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.