Stryker Sustainability Solutions: Tourniquet Cuffs Recalled for Mislabeling and Incorrect Port Configuration

Agency Publication Date: July 17, 2024

Summary

Stryker Sustainability Solutions has recalled 90 units of the Zimmer Tourniquet Cuff 30" (Blue) because the packaging is incorrectly labeled. While the box indicates the product is a dual port single bladder cuff, it actually contains a single port single bladder cuff. This discrepancy can lead to surgical delays or complications if the incorrect equipment is prepared for a procedure. These devices were distributed to healthcare facilities in California, Colorado, Illinois, Michigan, Oregon, and Wisconsin.

Risk

The mismatch between the label and the actual device could cause a delay in surgery if the surgical team discovers they have a single-port cuff when a dual-port system is required for the patient's procedure.

What You Should Do

Identify if you have the affected product by checking the packaging for REF: 60-7070-005, Zimmer Tourniquet Cuff 30" (Blue), and Lot number 0000564862.
Verify the UDI number 00885825015411 on the product label to confirm it matches the recalled batch.
Examine the device inside the packaging to see if it contains a single port instead of the dual port indicated on the label.
Contact your healthcare provider or Stryker Sustainability Solutions directly at their Tempe, Arizona facility to report affected inventory and arrange for further instructions.
Contact the FDA for additional questions or to report quality issues at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for guidance

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

Affected Products

Product: Zimmer Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder

Model / REF:

60-7070-005

UPC Codes:

00885825015411

Lot Numbers:

0000564862

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94824

Status: Active

Manufacturer: Stryker Sustainability Solutions

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 90 units

Distributed To: California, Colorado, Illinois, Michigan, Oregon, Wisconsin

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 REF: 60-7070-005, Zimmer Tourniquet Cuff 30" (Blue), and Lot number 0000564862.

Verify the UDI number 00885825015411 on the product label to confirm it matches the recalled batch.

Examine the device inside the packaging to see if it contains a single port instead of the dual port indicated on the label.

Contact your healthcare provider or Stryker Sustainability Solutions directly at their Tempe, Arizona facility to report affected inventory and arrange for further instructions.

Contact the FDA for additional questions or to report quality issues at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.