BEUDAMED
    FDA Recall Terminated

    The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.

    Recall: Z-0947-2011 · Initiated October 4, 2010

    Recall

    Recall Number
    Z-0947-2011
    Event Number
    57470
    Firm
    Stryker Instruments Division of Stryker Corporation
    FEI Number
    1811755
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 4, 2010
    Posted
    January 25, 2011
    Terminated
    June 6, 2011
    Address
    4100 East Milham Ave., Kalamazoo, MI, 49001

    Description

    The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.

    Reason

    There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.

    Action

    Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge. For questions regarding this recall call (269) 323-7700.

    Distribution

    Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK.

    Quantity

    490