Cook Incorporated: Check-Flo Performer Introducer Set Recalled for Cap Disconnection Risk

Agency Publication Date: October 9, 2024

Summary

Cook Medical is recalling 50 units of the Check-Flo Performer Introducer Set because the white caps that connect the device shaft to the hub may disconnect. This medical device is intended for use as a guiding or introducer sheath during clinical procedures. If the cap detaches while in use, it could lead to procedural failure, blood loss, or air entering the blood vessels. Consumers and medical professionals should identify affected units by the specific lot number and part number, and contact the manufacturer for guidance.

Risk

The white cap provides a critical connection between the shaft and the hub of the introducer. If this cap disconnects during a procedure, it could result in blood loss, air embolism (air bubbles in the bloodstream), or the need for additional surgical intervention to resolve the failure.

What You Should Do

Identify if you have the affected product by checking the packaging for Reference Part Number RCF-5.0-35-45-J and Order Number G27242.
Specifically look for Lot Number 15506769 and UDI-DI 00827002272422 to confirm the device is part of this recall.
If you have an affected device, stop using it immediately and quarantine the product to ensure it is not used in clinical procedures.
Contact Cook Medical or your healthcare facility's supply chain manager to coordinate the return of the affected lot.
Medical providers or patients with questions should contact Cook Incorporated at their Bloomington, Indiana location (750 N Daniels Way) or call the manufacturer for further instructions and potential refund or replacement information.
For additional information, you may contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Removal of affected lot from the market.

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

Affected Products

Product: Check-Flo Performer Introducer Set

Model / REF:

RCF-5.0-35-45-J

G27242

UPC Codes:

00827002272422

Lot Numbers:

15506769

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95405

Status: Active

Manufacturer: Cook Incorporated

Sold By: Medical distributors; Hospitals; Clinical facilities

Manufactured In: United States

Units Affected: 50 units

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

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.

Summary

What You Should Do

Identify if you have the affected product by checking the packaging for Reference Part Number RCF-5.0-35-45-J and Order Number G27242.

Specifically look for Lot Number 15506769 and UDI-DI 00827002272422 to confirm the device is part of this recall.

If you have an affected device, stop using it immediately and quarantine the product to ensure it is not used in clinical procedures.

Contact Cook Medical or your healthcare facility's supply chain manager to coordinate the return of the affected lot.

Medical providers or patients with questions should contact Cook Incorporated at their Bloomington, Indiana location (750 N Daniels Way) or call the manufacturer for further instructions and potential refund or replacement information.

For additional information, you may contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.