Recall Z-2677-2017 ยท FRN Pump, Infusion
ICU
The Plum A+ Infusion Systems are a multipurpose 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. The pumps are available in single channel and in triple channel pumping mechanism types.
| Date | Jul 7, 2017 (initiated Feb 1, 2013) |
| Status | Terminated |
| Reason | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Root cause | Other |
| Action | Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility. |
| Quantity | 71 units |
| Distribution | Nationwide, Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc., Apr 24, 2007 |