Z-0666-2010
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 #M4268882 used with InfoVAC Model M825999,, InvoVac... 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-0666-2010
- 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 #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.
- Product code
- OMP Negative Pressure Wound Therapy Powered Suction Pump
- 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
- 24,640
- Distribution
- Nationwide and Canada
- Product codes and lots
- Device Serial Numbers: InvoVAC - VERR00001-10301; VFTR00121-VFTR00178; VCOK00001-VCOK44429; VCPL05419; VCQK09226-VCQK09303; VOCK08493; VOCK09154; VOCK09898; and VOCK09899. InvoVac Canadian - VFFR0001-VFFR00835; VDQK00001 - VDQK00075; Vac ATS - VCDE01057-VCDE17172.
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.
