Z-0663-2010
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204...
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 #4102204 used with Tricell 60601 Model 212857, First Step... 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-0663-2010
- 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 #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.
- 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
- 10,520
- Distribution
- Nationwide and Canada
- Product codes and lots
- Device Serial Numbers Affected: Tricell 60601 - Serial Numbers FSUK00011-FSUK01400; used with First Step Select - Serial Numbers FWSK00001-FSWK02393; and used with Plexipulse - Serial Numbers PPGK00001-PPGK00226.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
