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
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
