Recall Z-1644-2011 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well
| Date | Mar 14, 2011 (initiated Feb 14, 2011) |
| Status | Terminated |
| Reason | Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Hospira, sent "URGENT DEVICE RECALL" letters dated February 14, 2011 to their customers on the same date. The letter described the product, problem and action to be taken by the customers. The Customer/Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Globa |
| Quantity | 144,477 pumps |
| Distribution | Worldwide distribution: United States including the U.S. Virgin Islands and Puerto Rico, and countries including: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 Abbott Laboratories, Jun 5, 2001 |
| K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Aug 24, 2004 |
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 Hospira, Inc., Apr 24, 2007 |
| K982159 | ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories, Jan 12, 1999 |