Recall Z-1832-2016 ยท FRN Pump, Infusion
Hospira Inc.
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The Plum 360 infuser features Concurrent, Secondary, and Piggyback infusions. A posit
| Date | Mar 25, 2016 |
| Status | Terminated |
| Reason | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure. |
| Root cause | Process control |
| Action | Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 2016, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax n |
| Quantity | 1490 infusion pumps. |
| Distribution | U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE Hospira, Inc., Jan 16, 2015 |