Foryou NPWT: Negative Pressure Wound Therapy by 4L Health

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Industry News

  • FDA: 37,437 NPWT Pump Cords Recalled by KCI
  • 25/01/2010

  • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86549

    Date Posted January 25, 2010
    Recall Status1 Terminated on January 21, 2011
    Recall Number Z-0665-2010
    Recall Event ID 53802
    Premarket Notification
    510(K) Number
    K063692 
    Product Classification Negative Pressure Wound Therapy Powered Suction Pump - Product Code OMP
    Product AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.
    Code Information Device Serial Numbers: Activac - VDZR00001-VDZR26649; and VCQK00001 - VCQK19781; ActiVAC (Canadian) - VDRK00001 - VDRK00085; VEPR00001 - VEPR01050; and VFSR00150 - VFSR01790.
    Recalling Firm/
    Manufacturer
    KCI USA, Inc.
    4958 Stout Dr
    San Antonio, Texas 78219-4334
    Manufacturer Reason
    for Recall
    Power cords may crack and fail inside plug with potential for fire hazard.
    FDA Determined
    Cause 2
    COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
    Action Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product. For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
    Quantity in Commerce 37,437
    Distribution Nationwide and Canada
    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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