Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0662-2010

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079...

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 #4100079 used with Kinair IV Model 22600, Kinair IV 60601... 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-0662-2010
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 #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.
Product code
IOQ Bed, Flotation Therapy, 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
4,637 units
Distribution
Nationwide and Canada
Product codes and lots
Device serial numbers affected: Kinair IV: KAPK00523 - KAPK00691; Kinair IV 60601: KAUK00001 - KAUK00134; Triadyne Proventa: TDDK0001 - TDDK00367; Therapulse ATP: TPNK00001 - TPNK00177; Kinair Medsurg: 1440-1441, KAS01524, KASK01004 - KASK02930; and Kinair Medsurg Pulse: KATK00001 - KATK00655