Stryker Instruments Div. of Stryker Corporation recalls Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tub…

Recall date

March 26, 2015

Source

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

Recall number

Z-1573-2015

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.

Why it was recalled

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

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

What was recalled

Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.