FDAClass IMay 7, 2014

Abbott Acclaim Infusion Pump Designed to deliver recall

Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a…

Why was Abbott Acclaim Infusion Pump Designed to deliver recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a…
Recalling firm
Hospira Inc.
Quantity
13,218 infusion pumps total
Distribution
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.
Recall date
May 7, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls