Recall Z-0664-2010
KCI USA, Inc. · initiated November 4, 2009
Product
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988
Codes / lots: Device Serial Numbers: First Step All-In-One 35 Inch Canadian French - FTGK00001-FTGK00106; First Step All-In One 35-Inch English - FTCK00001-FTCK00624; Therakair Visio Canadian 800 Wids; Therakair Visio Canadian 900 Wids; Airworks Sure Std. 110V-Canada; Airworks Sure 80CM Wide, 110V - Canada; Product Assy-Provicare Std. 110V-Canada; and Product Assy-Proficare 80CM wide, 110V-Canada.
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-0664-2010
- Initiated
- November 4, 2009
- Posted by FDA
- January 25, 2010
- Terminated
- January 21, 2011
- Product code
- IKY – Mattress, Flotation Therapy, Non-Powered
- Quantity
- 1,384
- 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-0665-2010 | 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 |