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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Medical Devices/Home Healthcare

Hospira Inc.: Acclaim Encore Infusion Pumps Recalled for Broken Door Assemblies

Agency Publication Date: July 18, 2014
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Summary

Hospira Inc. is recalling 2,503 Hospira/Abbott Acclaim Encore infusion pumps because of reports that the door assembly can break. The Acclaim Encore pump is used to deliver essential fluids, blood components, and nutrition to patients. If the door assembly is damaged, it may not hold the tubing correctly, which can lead to unrestricted fluid flow or prevent the pump from operating at all. This recall affects various serial numbers under List Number 12569 sold nationwide across the United States.

Risk

A broken door assembly can prevent the pump's tubing from being seated properly, which may result in unrestricted flow of medicine or fluids into a patient, potentially leading to over-infusion. Additionally, if the door cannot be closed, the pump will fail to operate, which could delay critical treatments.

What You Should Do

  1. Locate your Hospira/Abbott Acclaim Encore infusion pump and check the List Number and Serial Number on the device label.
  2. Verify if your unit is affected by checking for List Number 12569 and comparing your serial number against the extensive list of over 2,500 affected codes, including 13733228, 13734668, and many others in the 1373 series.
  3. Inspect the door assembly of the pump for any visible cracks, breaks, or difficulty in closing the door securely.
  4. If the door assembly appears broken or will not close properly, stop using the pump immediately and remove it from patient care.
  5. Contact your healthcare provider or Hospira/Abbott (now part of ICU Medical) for instructions on how to receive a repair or replacement for the affected hardware.
  6. For further questions or technical assistance regarding this recall, contact the manufacturer directly at their Lake Forest, Illinois headquarters or via their customer support channels.
  7. For additional information, you may contact the FDA's Center for Veterinary Medicine or the general FDA consumer hotline at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

๐Ÿ“‹Other Action

Contact ICU Medical (Hospira) for investigation and resolution of broken door assemblies.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Acclaim Encore Infusion Pump
Model:
List Number: 12569
Lot Numbers (1279):
13733228
13734668
13733008
13733509
13733048
13734803
13733014
13733062
13734655
13734993
13734378
13734376
13734512
13734831
13734978
13734584
13734762
13733065
13734554
13734594
13734610
13734612
13734771
13734973
13733032
13734396
13734900
13734996
13733547
13734357
13734726
13734666
13733194
13733550
13734436
13734551
13734574
13734597
13734811
13733230
13734171
13734793
13733000
13733504
13734767
13734799
13734817
13734904
13734905
13734988

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 67581
Status: Resolved
Manufacturer: Hospira Inc.
Sold By: Hospira; Abbott; medical distributors
Manufactured In: United States
Units Affected: 2,503 pumps
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, District of Columbia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response