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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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Critical RiskFDA Device
Medical Devices/Home Healthcare

Fresenius Medical Care Holdings, Inc.: stay-safe Catheter Extensions and Adapters Recalled for Tubing Contamination

Agency Publication Date: March 26, 2024
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Summary

Fresenius Medical Care is recalling over 2.1 million stay-safe catheter extensions and adapters because the peroxide cross-linked tubing can release chemical contaminants known as NDL PCBAs into the fluid path. These affected medical devices, including the Safe Lock and Luer Lock models, were distributed nationwide in the United States. While the firm has initiated this voluntary recall via letter, consumers using these specific dialysis accessories should be aware of the potential for chemical exposure. If you use any stay-safe extension or adapter listed in this recall, you should contact your healthcare provider or the manufacturer for further instructions.

Risk

The tubing in these devices can leach non-dioxin-like polychlorinated biphenyls (NDL PCBAs) during use, which may pose a risk of chemical exposure and potential adverse health effects for patients undergoing dialysis treatments.

What You Should Do

  1. Check your medical supplies for stay-safe products, specifically the Safe Lock Catheter Ext. 12 in (Model 050-95001), Luer Lock Adapter 4 in (Model 050-95003), Luer Lock Catheter Ext. 12 in (Model 050-95004), Luer Lock Catheter Ext. 18 in (Model 050-95005), and Luer Catheter Ext. 6 in (Model 050-95013).
  2. Verify the UDI/DI on the product bag or case; for example, the stay-safe Safe Lock 12 in extension has UDI/DI 00840861100767 (Bag) or 10840861100764 (Case).
  3. Because this recall affects all lots of the listed model numbers, you should consider any matching model in your possession to be part of the recall.
  4. Contact your healthcare provider or Fresenius Medical Care Holdings, Inc. immediately for instructions on how to handle affected products and to discuss any health concerns.
  5. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: stay-safe /Safe Lock Catheter Ext. 12 in
Model / REF:
050-95001
UPC Codes:
00840861100767
10840861100764
Lot Numbers:
All lots
Product: stay-safe /Luer Lock Adapter 4 in
Model / REF:
050-95003
UPC Codes:
00840861100774
10840861100771
Lot Numbers:
All lots
Product: stay-safe /Luer Lock Catheter Ext. 12 in
Model / REF:
050-95004
UPC Codes:
00840861100781
10840861100788
Lot Numbers:
All lots
Product: stay-safe /Luer Lock Catheter Ext. 18 in
Model / REF:
050-95005
UPC Codes:
00840861100798
10840861100795
Lot Numbers:
All lots
Product: stay-safe /Luer Catheter Ext. 6 in
Model / REF:
050-95013
UPC Codes:
00840861100804
10840861100801
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94084
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Fresenius Medical Care Holdings, Inc.; Medical distributors
Manufactured In: United States
Units Affected: 5 products (114,982 eaches; 828,954 eaches; 663,221 eaches; 479,978 eaches; 105,700 eaches)
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.

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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.