Recall Z-0009-2012 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 Product Usage: The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospit
| Date | Oct 4, 2011 (initiated Sep 16, 2011) |
| Status | Terminated |
| Reason | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. |
| Root cause | Software design |
| Action | The firm, Hospira sent "URGENT DEVICE RECALL" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced |
| Quantity | 265,105 pumps |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Ita |
| 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 |