Z-1482-2014 Class I Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-1482-2014 was initiated by Hospira Inc. on Oct 31, 2013 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated Aug 16, 2017). Affected quantity: 13,218 infusion pumps total.

Recall Details

Product Type
Devices
Report Date
May 7, 2014
Initiation Date
Oct 31, 2013
Termination Date
Aug 16, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,218 infusion pumps total

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1482-2014
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.