Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0664-2010

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord...

KCI USA, Inc. / initiated 2009-11-04 / Terminated / root cause: manufacturing process

KCI USA, Inc. began a recall of 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... on . The reason FDA records is "Power cords may crack and fail inside plug with potential for fire hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0664-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KCI USA, Inc.
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
Product code
IKY Mattress, Flotation Therapy, Non-Powered
Reason for recall
Power cords may crack and fail inside plug with potential for fire hazard.
Root cause tag
manufacturing process
FDA 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 in commerce
1,384
Distribution
Nationwide and Canada
Product codes and 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.