Recall Z-1833-2016 ยท FRN Pump, Infusion
Hospira Inc.
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administrat
| 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 | 2567 Plum A+ 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 |