Recall Z-0665-2010
KCI USA, Inc. · initiated November 4, 2009
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.
Codes / lots: Device Serial Numbers: Activac - VDZR00001-VDZR26649; and VCQK00001 - VCQK19781; ActiVAC (Canadian) - VDRK00001 - VDRK00085; VEPR00001 - VEPR01050; and VFSR00150 - VFSR01790.
Reason for recall
Power cords may crack and fail inside plug with potential for fire hazard.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0665-2010
- Initiated
- November 4, 2009
- Posted by FDA
- January 25, 2010
- Terminated
- January 21, 2011
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 37,437
- Distribution
- Nationwide and Canada
- Recalling firm
- KCI USA, Inc., San Antonio, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0662-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | 11/04/2009Terminated |
| Z-0663-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | 11/04/2009Terminated |
| Z-0664-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | 11/04/2009Terminated |
| Z-0666-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | 11/04/2009Terminated |
| Z-0667-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | 11/04/2009Terminated |