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U.S. Department of Health and Human Services

Class 2 Device Recall AC Power Cords

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  Class 2 Device Recall AC Power Cords see related information
Date Initiated by Firm November 04, 2009
Date Posted January 25, 2010
Recall Status1 Terminated 3 on January 21, 2011
Recall Number Z-0664-2010
Recall Event ID 53802
Product Classification Mattress, flotation therapy, non-powered - Product Code IKY
Product AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988
Code Information Device Serial Numbers: First Step All-In-One 35 Inch Canadian French - FTGK00001-FTGK00106; First Step All-In One 35-Inch English - FTCK00001-FTCK00624; Therakair Visio Canadian 800 Wids; Therakair Visio Canadian 900 Wids; Airworks Sure Std. 110V-Canada; Airworks Sure 80CM Wide, 110V - Canada; Product Assy-Provicare Std. 110V-Canada; and Product Assy-Proficare 80CM wide, 110V-Canada.
Recalling Firm/
Manufacturer		 KCI USA, Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact
210-255-5571
Manufacturer Reason
for Recall		 Power cords may crack and fail inside plug with potential for fire hazard.
FDA Determined
Cause 2		 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 1,384
Distribution Nationwide and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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