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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

Hospira Inc.: Plum LifeCare 5000 and XL Infusion Pumps Recalled for Broken Door Roller Pins

Agency Publication Date: July 18, 2014
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Summary

Hospira Inc. is recalling approximately 25,843 infusion pumps from the Plum LifeCare 5000 and Plum XL families because a metal pin in the door roller assembly can break. If this pin breaks, the pump door cannot lock the medication cassette into the correct position, which may cause the door to stay open or trigger false alarms. This issue affects several models, including the LifeCare 5000 (Plum 1.6) and various Plum XL devices used in hospitals and home care settings. To ensure continued safety, consumers should contact their healthcare provider or the manufacturer for repair or replacement instructions.

Risk

A broken door roller pin prevents the device from securing the fluid cassette properly, which can stop the pump from delivering critical medications or fluids. This failure could result in a delay of treatment or inaccurate dosing, potentially leading to serious health complications for the patient.

What You Should Do

  1. Locate the List Number and serial number on the back or side of your infusion pump to determine if it is affected. Affected units include LifeCare 5000 (List 02507) and Plum XL Family (Lists 11555, 11855, 11859, 11781, 11845, and 11846).
  2. Inspect the pump for any difficulty in closing the door or a loose-feeling door handle, which may indicate the internal roller pin has broken.
  3. Monitor the device for specific error messages, including 'cassette/door' alarms or 'false occlusion' alerts, which are signs that the roller assembly is failing.
  4. Contact your healthcare provider or Hospira/ICU Medical Inc. at 275 N Field Dr, Lake Forest, Illinois, 60045-2579, for information regarding the repair or replacement of the affected units.
  5. If you are using these devices in a home care environment, notify your equipment provider or medical professional immediately to arrange for a functional replacement device.
  6. Report any device failures or patient incidents to the FDA's Center for Veterinary Medicine to assist with ongoing safety monitoring.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated repair or replacement process via letter notification.

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

Affected Products

Product: LifeCare 5000 Pump (Plum 1.6)
Model:
List Number 02507
Lot Numbers:
All Serial Numbers
Product: Plum XL Family Infusion Pump (List 11555)
Model:
List Number 11555
Lot Numbers:
All Serial Numbers
Product: Plum XL Family Infusion Pump (List 11855)
Model:
List Number 11855
Lot Numbers:
All Serial Numbers
Product: Plum XL Family Infusion Pump (List 11859)
Model:
List Number 11859
Lot Numbers:
All Serial Numbers
Product: Plum XL Family Infusion Pump (List 11781)
Model:
List Number 11781
Lot Numbers:
All Serial Numbers
Product: Plum XL Family Infusion Pump (List 11845)
Model:
List Number 11845
Lot Numbers:
All Serial Numbers
Product: Plum XL Family Infusion Pump (List 11846)
Model:
List Number 11846
Lot Numbers:
All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68257
Status: Resolved
Manufacturer: Hospira Inc.
Sold By: Hospitals; Home care environments
Manufactured In: United States
Units Affected: 3 products (List Number 02507: 132,889 pumps; List Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859:; List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846:)
Distributed To: Nationwide

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