—#137181

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.

FDA product code: FQH — Lavage, Jet
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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

Why it was recalled

Potential sterility breach in the packaging.

Root cause (FDA determination)

Package design/selection

Action the firm took

Stryker sent Customer Notification Letters on 05/20/2015 through Certified mail via USPS. Customers are asked to do the following: Immediately review this Recall Notification. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not have any affected product on hand. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Form to Stryker Instruments Regulatory Department. Upon receipt of the Business Reply Form, if you have recalled product on hand, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled WoundCare Replacement kits to Stryker.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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.

Timeline

Recall initiated: 2015-05-08
Posted by FDA: 2015-07-13
Terminated: 2015-10-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.