Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: ...

FDA Device Recall #Z-1802-2020 — Class II — October 9, 2019

Recall Summary

Recall Number Z-1802-2020
Classification Class II — Moderate risk
Date Initiated October 9, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Sustainability Solutions
Location Tempe, AZ
Product Type Devices
Quantity 90

Product Description

Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.

Reason for Recall

Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

Distribution Pattern

US Nationwide distribution including the states of SC, TX, UT, NY, AR

Lot / Code Information

Lot Number 10237165

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Z-2268-2024 Class II Stryker Sustainability Solutions, BW Lasso 2515... May 10, 2024
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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.