FDA-Device2015-07-22Class II
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.
Stryker Instruments Div. of Stryker Corporation
Hazard
Potential sterility breach in the packaging.
Sold states
Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
Affected count
5,328 each (444 boxes)
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2062-2015Don't want to check this manually?
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