Reported Jul 22, 2015 · Terminated

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100-…

Stryker Instruments Div. of Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

Is this the product you have?

  • 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.
Lot codes and dates
    • 0210-312-000: 12138012
    • 12203012
    • 12229012
    • 12256012
    • 12293012
    • 12314012
    • 12338012
    • 13086012
    • 13140012
    • 13192012
    • 0210-318-000: 14140012
    • 14258012
    • 0210-318-100: 12294012
    • 13051012
    • 0210-318-200: 12143012
    • 12293012
    • 13066012
    • 14037012
    • 14112012
Amount recalled
5,328 each (444 boxes)

Where it was sold

Why it was recalled

Potential sterility breach in the packaging.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 19, 2015 · Data as of Sep 19, 4:50 PM UTC

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