Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

ChemoLock Close Vial Spikes Recalled for Incorrect Labeling

Agency Publication Date: December 9, 2024
Share:
Sign in to monitor this recall

Summary

ICU Medical, Inc. is recalling approximately 6,000 units of the ChemoLock Close Vial Spike (model CL-80) because the products were incorrectly packaged and labeled. The ChemoLock is a needle-free device used by healthcare personnel to prevent the transfer of environmental contaminants and to avoid accidental needle sticks or exposure to hazardous medications. No incidents or injuries have been reported to date regarding this issue.

Risk

Incorrect packaging and labeling could lead healthcare workers to use the wrong device or apply it incorrectly, which may result in exposure to cytotoxic medications or a loss of sterility. These errors pose a risk of injury or infection to both medical staff and patients.

What You Should Do

  1. This recall affects the ChemoLock Close Vial Spike (REF CL-80) with Lot Number 13959938 and Unique Device Identifier (UDI) code (01)10887709057125(17)290401(30)50(10)13959938.
  2. Stop using the recalled device immediately to avoid potential exposure or contamination risks.
  3. Contact ICU Medical, Inc. or your healthcare distributor to arrange for the return, replacement, or correction of the affected spikes.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report any adverse events.

Your Remedy Options

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

Affected Products

Product: ChemoLock Close Vial Spike
Model / REF:
CL-80
Lot Numbers:
13959938
UDI:
(01)10887709057125(17)290401(30)50(10)13959938

Quantity: 6000 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95649
Status: Active
Manufacturer: ICU Medical, Inc.
Sold By: Healthcare distributors
Manufactured In: United States
Units Affected: 6000 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.