Foryou NPWT: Negative Pressure Wound Therapy by 4L Health

News & Events

Industry News

  • FDA: 71,329 Renasys Ports of NPWT Dressing Kits Recalled by Smith & Nephew
  • 26/01/2012

  • http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=100642

    Date Posted January 26, 2012
    Recall Status1 Terminated on April 30, 2012
    Recall Number Z-0875-2012
    Recall Event ID 58935
    Premarket Notification
    510(K) Number
    K082211 
    Product Classification Negative Pressure Wound Therapy Powered Suction Pump - Product Code OMP
    Product ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.
    Code Information Product Code Number: 66800694 Lot numbers: 50512962, 50512969, 50512974, 50513087, 50514672, 50513073, 50513074, 50517647, 50516110, 50539644, 50539645, 50539646, 50539647, 50555348, 50555349, 50555351, 50539648, 50546339, 50546340, 50548244, 50548245, 50548246, 50548247 and 50548248.
    Recalling Firm/
    Manufacturer
    Smith & Nephew Inc.
    970 Lake Carillon Dr
    Ste 110
    Saint Petersburg, Florida 33716-1130
    For Additional Information Contact Terry McMahon
    727-399-3785
    Manufacturer Reason
    for Recall
    On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.
    FDA Determined
    Cause 2
    COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
    Action Smith & Nephew, Inc., Wound Management sent an URGENT DEVICE RECALL letter dated December 14, 2010, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to immediately identify and isolate the recalled lots in their inventory, complete and fax the response form, and return any affected products to APL Logistics, Inc. in Suwanee, GA. For questions in general, please contact the Customer Care Center at 1-800-876-1261.
    Quantity in Commerce 71329 units
    Distribution Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, GA, MA, MI, MO, MS,.NC, NY,OR, TN, and WI. and the countries of: Australia, Canada, China, England, Germany, Ireland and Singapore.
    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.

Copyright © 4L Health Co., Ltd. & Foryou Medical Electronics Co., Ltd. All Rights Reserved.