Recall Z-3286-2011 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005. 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 f
| 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 | 120 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
| K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Dec 17, 2008 |