Stryker Instruments Div. of Stryker Corporation recalls 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound…

Recall date

March 26, 2015

Source

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

Recall number

Z-1564-2015

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

1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.