Date Initiated by Firm |
November 04, 2009 |
Date Posted |
January 25, 2010 |
Recall Status1 |
Terminated 3 on January 21, 2011 |
Recall Number |
Z-0663-2010 |
Recall Event ID |
53802 |
510(K)Number |
K944567
|
Product Classification |
Bed, flotation therapy, powered - Product Code IOQ
|
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. |
Code Information |
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. |
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 |
10,520 |
Distribution |
Nationwide and Canada |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|
510(K) Database |
510(K)s with Product Code = IOQ and Original Applicant = KINETIC CONCEPTS, INC.
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