Recall Z-0665-2010 ยท 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 #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.
| 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 | 37,437 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063692 | V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 Kci USA, Inc., Jun 7, 2007 |