Recall Z-2730-2016 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. 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.
| Date | Sep 6, 2016 (initiated Feb 6, 2013) |
| Status | Terminated |
| Reason | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Root cause | 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 | 357,778 total |
| Distribution | United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Dec 17, 2008 |