BEUDAMED
    FDA Recall Terminated

    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.

    Recall: Z-2242-2013 · Initiated August 5, 2013

    Recall

    Recall Number
    Z-2242-2013
    Event Number
    66052
    Firm
    3M Company Health Care Business 3M Center
    FEI Number
    2110898
    Product Code
    ITG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 5, 2013
    Posted
    September 18, 2013
    Terminated
    June 16, 2014
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144

    Description

    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.

    Reason

    3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no repo

    Action

    3M sent a Voluntary Product Recall Notification letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to examine their inventory and set aside any affected lots subject to the recall notice. Customers were asked to inform all departments of any affected lots and provide them with a copy of the Notification letter that instructs them to contact their 3M distributor for alternative options. All affected products were to be returned to the 3M distributor they were purchased from. Customers with questions were instructed to contact the 3M Customer Helpline at 1-800-228-3957. For questions regarding this recall call 651-733-1110.

    Distribution

    Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA..

    Quantity

    1207 cases (4 puches per case, 20 rolls per pouch)