Stryker Instruments Div. of Stryker Corporation recalls 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- W…

Recall date

May 8, 2015

Source

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

Recall number

Z-2062-2015

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.

Why it was recalled

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

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.