Recall Z-3284-2011 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 w
| Date | Sep 29, 2011 (initiated Sep 16, 2011) |
| Status | Terminated |
| Reason | Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur. |
| Root cause | Nonconforming Material/Component |
| Action | Hospira, Inc. sent an "URGENT DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. The letter instructs customers on how to prevent occurrences of continuous recycling/rebooting during start-up. A reply form was attached to the letter for customers to complete and return via fax to 1-888-345-5358. Contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance or information regarding this notice. |
| Quantity | 265,105 pumps |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the U. S. 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, Ital |
| 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 |