Z-1482-2014Class I

Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell...

Name: Z-1482-2014 Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell...
Creator: Hospira Inc.
Published: 2013-10-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-10-31 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide... on 2013-10-31. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1482-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-31
Posted: 2014-05-01
Terminated: 2017-08-16
Recalling firm: Abbott Medical
Product: 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.
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: URGENT MEDICAL DEVICE CORRECTION letters, dated October 31, 2013, were sent to all direct accounts. The letters identified the affected product, as well as the reason for recall, risk to health, and instructions for device users. Users are to inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy by following the provided instructions. The letter also included instructions for recipients to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions; and complete the attached reply form and return it to the fax number or e-mail address on the form. Customers are to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain additional reply forms if needed. If the devices were further distributed, those customers should be notified and asked to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. The letter reminds customers that Hospira is retiring the Acclaim Encore infusion pump and will no longer support them as of December 31, 2014.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1482-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1482-2014	Class I	Terminated	Voluntary: Firm initiated	2014-05-07	2014-05-01
Z-1483-2014	Class I	Terminated	Voluntary: Firm initiated	2014-05-07	2014-05-01

Product code FRN

K991501Class IIAcclaim Infusion PumpAbbott Laboratories / cleared 1999-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)