BEUDAMED
    FDA Recall Terminated

    Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    Recall: Z-1846-2012 · Initiated May 9, 2012

    Recall

    Recall Number
    Z-1846-2012
    Event Number
    61942
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 9, 2012
    Posted
    June 21, 2012
    Terminated
    February 12, 2014
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    Reason

    Potential for the sterility barrier to be compromised.

    Action

    The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2012 via federal express to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (note: units from affected lots may have been incorporated into Covidien BEST PRACTICE KITS; evaluate kits for affected lots). All affected ROTICULATOR units must be returned. The customers were also instructed to complete and return the attached ROTICULATOR Single Use Stapler Recalled Product Return form via fax to: (800) 895-6140 or email to: [email protected], even if you do not have any of the affected units, and include a copy of completed form with products being returned. Customers who received product directly from Covidien should contact Covidien Customer Service at [email protected] or (800) 722-8772, option 1, prior to returning affected products to Covidien, Field Returns Department, at 195 McDermott Road, North Haven, CT 06473; if received from distributor, return form and contact distributor directly. If you have any questions or concerns, please do not hesitate to contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.

    Distribution

    Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA¿A France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.

    Quantity

    13531 units