FDAFDA · Food and drugs·Recall number Z-0205-2014
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Published November 20, 2013 · Recall initiated: February 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.
- Lot
- List No. 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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