FDAFDA · Food and drugs·Recall number Z-1482-2014
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Published May 7, 2014 · Recall initiated: October 31, 2013
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 customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Lot
- List Number: 12032; Serial Numbers: 12322921, 12323859, 12322780, 12322801, 12322810, 12322812, 12322878, 12322880, 12322887, 12322896, 12322903, 12322904, 12322911, 12322917, 12322936, 12322939, 12323867, 12322916, 12323056, 12321139, 12324767, 12324854, 12324802, 12322873, 12324375, 1231453, 1231610.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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