Date Initiated by Firm | November 04, 2009 |
Date Posted | January 25, 2010 |
Recall Status1 |
Terminated 3 on January 21, 2011 |
Recall Number | Z-0665-2010 |
Recall Event ID |
53802 |
510(K)Number | K063692 |
Product Classification |
Negative pressure wound therapy powered suction pump - Product Code OMP
|
Product | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013. |
Code Information |
Device Serial Numbers: Activac - VDZR00001-VDZR26649; and VCQK00001 - VCQK19781; ActiVAC (Canadian) - VDRK00001 - VDRK00085; VEPR00001 - VEPR01050; and VFSR00150 - VFSR01790. |
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 | 37,437 |
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.
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510(K) Database | 510(K)s with Product Code = OMP
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