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 Recall Z-2062-2015 · Posted 2015-07-13
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFQH
Date Initiated2015-05-08
Date Terminated2015-10-19
Product Quantity5,328 each (444 boxes)
Reason for Recall
Potential sterility breach in the packaging.
Firm Action
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 ([email protected]) 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.
Root Cause
Package design/selection
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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