Recall Z-0666-2010 · OMP Negative Pressure Wound Therapy Powered Suction Pump

KCI USA, Inc.

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.

Date	Jan 25, 2010 (initiated Nov 4, 2009)
Status	Terminated
Reason	Power cords may crack and fail inside plug with potential for fire hazard.
Root cause	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	24,640
Distribution	Nationwide and Canada
FDA record	Open on fda.gov

510(k) clearances named in this recall

K062227	V.A.C. THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.), Oct 4, 2006
K063740	V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 Kci USA, Inc., Jun 7, 2007