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  • FDA: 2,717 NPWT Pumps Recalled by Smith & Nephew
  • 03/11/2010


    Date Posted November 03, 2010
    Recall Status1 Terminated on November 10, 2010
    Recall Number Z-0310-2011
    Recall Event ID 56825
    Premarket Notification
    510(K) Number
    Product Classification Negative Pressure Wound Therapy Powered Suction Pump - Product Code OMP
    Product Smith & Nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England
    Recalling Firm/
    Smith & Nephew Inc.
    970 Lake Carillon Dr
    Ste 110
    Saint Petersburg, Florida 33716-1130
    For Additional Information Contact Terry McMahon
    Manufacturer Reason
    for Recall
    Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin
    FDA Determined
    Cause 2
    Action Smith & Nephew Inc. FEDEXed overnight an URGENT DEVICE RECALL letter dated January 27, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were to check their inventory and identify any affected product, fill out and return the response form by both mail and fax, and return the affected product with the prepaid Federal Express (FedEx) Ground label provided by Smith & Nephew. For any questions regarding this recall contact the Customer Care Center at (800) 876-1261.
    Quantity in Commerce 2717 units
    Distribution Worldwide Distribution - US including AL, AR, AZ, CA, GA, IL, IN, MA, MD, MD, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and UT and the countries of Australia, UK, South Africa, Canada, Puerto Rico, and New Zealand.
    Total Product Life Cycle TPLC Device Report

    1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
    2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

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