QUINTUBE Monitor Pack SPG Bulb Drain System recalled over sterility concerns

Recall date

January 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Leibinger GmbH & Co. KG recalls QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) A…

Recall number

Z-1149-2017

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.

Why it was recalled

An incorrect sterility status on the label, non-sterile products labeled as sterile

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System