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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 Device
Medical Devices/Monitoring Devices

Covidien LP: Palindrome Chronic Catheters Recalled for Missing Heparin Coating

Agency Publication Date: April 24, 2024
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Summary

Covidien LP is recalling approximately 1,183 Palindrome Precision Chronic Catheters because they may not have the heparin coating indicated on the label. This voluntary recall affects specific lots of the Palindrome Precision HSI Sport Pack and the Palindrome Precision H Catheter Kit used for hemodialysis and infusion. Without the intended heparin coating, patients may experience a loss of the clinical benefits the coating is designed to provide during treatment.

Risk

The absence of the heparin coating on these catheters can lead to a potential loss of treatment benefit and may increase the risk of complications during hemodialysis or apheresis procedures. While no specific injuries were mentioned in this notification, the mismatch between the product labeling and the actual device components poses a moderate risk to patient safety.

What You Should Do

  1. Identify your product by checking the packaging for Palindrome Precision HSI Chronic Catheter Sport Pack (14.5 Fr/Ch x 19 cm) with Model Number 8888119369P and Lot Number 2318500118.
  2. Check also for Palindrome Precision H Chronic Catheter Kit (14.5 Fr/Ch x 23 cm) with Model Number 8888145044CP and Lot Numbers 2228000089, 2201700103, or 2228000074.
  3. If you are a healthcare provider, immediately stop using and quarantine any affected products from these specific lots.
  4. Contact your healthcare provider if you have concerns about a catheter currently in use or if you have questions regarding your treatment history with these devices.
  5. Contact Covidien LP at their Mansfield, Massachusetts location or through your official Medtronic/Covidien representative for instructions on returning affected units and potential replacement or refund.
  6. For additional information, contact the FDA at 1-888-463-6332 or visit the FDA Medical Device Recalls website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Instructions

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

Affected Products

Product: Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm
Model / REF:
8888119369P
UPC Codes:
20884521157733
Lot Numbers:
2318500118
Product: Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm
Model / REF:
8888145044CP
UPC Codes:
20884521158082
10884521158085
Lot Numbers:
2228000089
2201700103
2228000074

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94266
Status: Active
Manufacturer: Covidien LP
Sold By: Authorized Medical Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 2 products (305 units; 878 units)
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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.