Official recall notice

FDA DeviceClass IINotable

Disposable Tourniquet Cuff 18 2 Line Recall (Oct 2026)

Product: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

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Product description

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Affected products

Lot Code: Model Number:DT-7218-02Q UDI-DI: UDI UDI (01) 00840001403314 All Lots produced from 01SEP2016 to 01MAR2023: S0922STY, S1101STY, R1201STY, Q1115STY, P1015STY, N0530STY

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