Recall Z-1702-2014 ยท FRN Pump, Infusion
Hospira Inc.
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
| Date | Jun 3, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion |
| Root cause | Component design/selection |
| Action | Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 24, 2014, to all affected customers via traceable UPS. The letters included instructions for recipients to: inspect the door roller assemblies; if a door roller or pin appears loose, broken or missing, remove the device from clinical service until the door assembly is replaced with a corrected door assembly and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. All devices requiring repair will be serviced and replaced with the existing design door and/or pin. Hospira is in the proces |
| Quantity | List Number 02507: 132,889 pumps |
| Distribution | Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911401 | ABBOTT LIFECARE 5000 PUMP Abbott Laboratories, May 28, 1991 |