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• 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.