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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.: LifeShield HemoSet Recalled for Incorrect Drip Rate Components

Agency Publication Date: June 27, 2014
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Summary

Hospira Inc. is recalling 3,893 units of the LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet because an incorrect component was used during manufacturing. This specific part, the lower lid of the set, was designed to dispense 10 drops per mL instead of the intended 15 drops per mL. These sets are used for the infusion of blood and blood products, and the incorrect drip rate could lead to inaccurate dosing of fluids or medications for patients.

Risk

The incorrect lower lid component causes a 33% discrepancy in gravity-fed delivery, dispensing only 10 drops per milliliter instead of the required 15 drops. This mismatch could lead to the unintended under-delivery or over-delivery of blood products or fluids, potentially resulting in serious patient harm depending on the criticality of the infusion rate.

What You Should Do

  1. Locate the product packaging and check for Product List Number 112410403 and Lot Numbers 280055H or 341005H.
  2. Immediately stop using any affected LifeShield HemoSet units identified with these specific lot numbers.
  3. If you have these products in your inventory, quarantine them to ensure they are not used for any patient procedures.
  4. Contact your healthcare provider or veterinarian if you believe a patient has received a transfusion using an affected device to determine if any follow-up care is necessary.
  5. Contact Hospira Inc. or the manufacturer for instructions on how to return the affected units and receive a replacement or refund.
  6. For additional questions or to report an issue, contact the FDA Consumer Complaint Coordinator at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Professional consultation and manufacturer contact

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

Affected Products

Product: LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette
Model:
112410403
11241-03
Lot Numbers:
280055H
341005H

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 67729
Status: Resolved
Manufacturer: Hospira Inc.
Sold By: Direct medical distribution
Manufactured In: United States
Units Affected: 3,893 sets
Distributed To: Florida, Iowa, Indiana, Kansas, Kentucky, Maine, Missouri, Montana, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington

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