Recall Z-1599-2011 ยท FRN Pump, Infusion
Hospira Inc.
Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11859
| Date | Mar 8, 2011 (initiated Feb 14, 2011) |
| Status | Terminated |
| Reason | Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting. |
| Root cause | Labeling design |
| Action | Hospira sent Urgent Device Recall letters dated February 14, 2011 to their customers on the same date, informing them that Hospira had received complaints of the Plum XL, XLM and XLD infusion pumps in which the audible alarm failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. Clinicians were instructed to weigh the risk associated with continued use of the device versus |
| Quantity | 145,963 pumps |
| Distribution | Worldwide distribution, including United States, the U.S. Virgin Islands, Puerto Rico, Argentina, Australia, Bahamas, Bahrain, Barbados, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, EI Salvador, Finland, France, Greece, Guatemala, Hong Kong, Hungar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010924 | MODIFICATION TO PLUM XL INFUSION PUMP Abbott Laboratories, Apr 6, 2001 |