Plum A+3 Infusion Pump System. List Number 12348. 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 Recall Z-2728-2016 · Posted 2016-09-06
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-02-06
Date Terminated2016-11-14
Product Quantity357,778 total
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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