ICU Medical, Inc.: Spinning Spiros Closed Male Luers Recalled for Potential Fluid Leaks

Agency Publication Date: November 23, 2020

Summary

ICU Medical, Inc. is recalling approximately 7,100 units of the Spinning Spiros Closed Male Luer (REF: AH2000S) due to a molding defect that can cause the device to leak. This veterinary medical device, used for secure fluid connections, may fail to maintain a closed system, leading to the loss of medication or exposure to hazardous substances. The affected products were distributed in Arizona and include four specific lot numbers: 4726922, 4751105, 4761825, and 4783375.

Risk

A molding defect in the spinning version of the male luer can cause fluid to leak from the connection point. This leakage can lead to dangerous delays in infusion, contamination of the sterile fluid path, accidental exposure to hazardous medications, or significant blood loss for the patient.

What You Should Do

Check your inventory for Spinning Spiros Closed Male Luer devices with the reference number REF: AH2000S.
Verify if your devices match one of the affected lot numbers: 4726922, 4751105, 4761825, or 4783375.
Immediately stop using any devices identified as part of these affected lots to prevent potential leaks or contamination.
Contact your healthcare provider or the manufacturer, ICU Medical, Inc., for further instructions and information regarding a potential refund or replacement.
For additional questions or to report issues, contact the FDA Consumer Complaint Coordinator in your state or call the FDA at 1-888-INFO-FDA.

Your Remedy Options

Other Action

Manufacturer Contact for Instructions

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

Affected Products

Product: Spinning Spiros Closed Male Luer, REF: AH2000S

Model:

AH2000S

Lot Numbers:

4726922

4751105

4761825

4783375

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86741

Status: Active

Manufacturer: ICU Medical, Inc.

Sold By: authorized distributors

Manufactured In: United States

Units Affected: 7100

Distributed To: Arizona

Agency Last Updated: December 2, 2020

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 · Raw API Response

Summary

What You Should Do

Check your inventory for Spinning Spiros Closed Male Luer devices with the reference number REF: AH2000S.

Verify if your devices match one of the affected lot numbers: 4726922, 4751105, 4761825, or 4783375.

Immediately stop using any devices identified as part of these affected lots to prevent potential leaks or contamination.

Contact your healthcare provider or the manufacturer, ICU Medical, Inc., for further instructions and information regarding a potential refund or replacement.

For additional questions or to report issues, contact the FDA Consumer Complaint Coordinator in your state or call the FDA at 1-888-INFO-FDA.