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AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with A

FDA device recall Z-0665-2010 · posted 2010-01-25 · Terminated

Recall details

Recalling firm
KCI USA, Inc.
Reason for recall
Power cords may crack and fail inside plug with potential for fire hazard.
Action taken
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.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
OMP
Quantity affected
37,437
Distribution
Nationwide and Canada
Date initiated
2009-11-04
Date posted
2010-01-25
Date terminated
2011-01-21
Location
San Antonio, TX

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Related 510(k) clearances

RecordFirmDate
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 (K063692)Kci USA, Inc.2007-06-07