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• 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.