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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/Diagnostic Equipment

VACUETTE SAFELINK Holders Recalled for Potential Blood Leakage

Agency Publication Date: January 3, 2025
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Summary

Approximately 188,800 VACUETTE SAFELINK Holders (REF: 450210) are being recalled because they may leak blood during use. The protective rubber sleeve on the device can bunch up and fail to retract properly, leading to potential leakage. No injuries or incidents have been reported, but consumers and healthcare facilities should stop using the affected units immediately.

Risk

The failure of the rubber sleeve to retract can cause blood to leak from the holder, which may expose healthcare providers or patients to bloodborne pathogens. There are currently no reports of injuries associated with this defect.

What You Should Do

  1. The recalled products are VACUETTE SAFELINK Holders with male luer locks, specifically model REF: 450210, lot number A240338Q, and an expiration date of February 15, 2027.
  2. Stop using the recalled product immediately.
  3. Contact Greiner Bio-One GmbH or your authorized medical distributor to arrange for the return, replacement, or correction of the affected devices.
  4. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VACUETTE SAFELINK Holder with male luer lock
Model / REF:
450210
Lot Numbers:
A240338Q (Exp 270215)
UDI:
19120049207487

Recall #: Z-0802-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95748
Status: Active
Manufacturer: Greiner Bio-One GmbH
Sold By: authorized medical distributors
Manufactured In: Austria
Units Affected: 188,800 pcs
Distributed To: Illinois, Pennsylvania

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.