Device product

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.

Z-2062-2015

May 08, 2015

Class II

Product summary

Firm: Stryker Instruments Div. of Stryker Corporation
Event: Event 71271
Status: Terminated
Classification: Class II
Quantity: 5,328 each (444 boxes)
Official record key: device-enforcement:Z-2062-2015

Official wording

Reason: Potential sterility breach in the packaging.

Code information: 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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential sterility breach in the packaging.