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U.S. Department of Health and Human Services

Class 2 Device Recall VISTA Negative Pressure Wound Therapy Charger

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  Class 2 Device Recall VISTA Negative Pressure Wound Therapy Charger see related information
Date Initiated by Firm August 07, 2008
Date Posted October 27, 2008
Recall Status1 Terminated 3 on October 01, 2009
Recall Number Z-0162-2009
Recall Event ID 49566
510(K)Number K042134  
Product Classification Battery Charger - Product Code BTA
Product GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China.

Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.
Code Information SSN: RoHS02492601 Last 4 digits of SSN identifies affected products: 05/08; 06/08; 07/08; 08/08; 09/08; 10/08; 11/08; 12/08; 13/08; 14/08 and 15/08.
Recalling Firm/
Manufacturer		 Smith And Nephew, Inc. Wound Management Division
11775 Starkey Road
Largo FL 33773-4727
For Additional Information Contact
727-399-3785
Manufacturer Reason
for Recall		 External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Each consignee was notified by recall letter (Field Correction Notification) dated 8/7/08 via FEDEX overnight. Within five (5) working days of the date of the customer notification a Smith & Nephew representative will contact the customers to assess their inventory and schedule delivery of replacement battery chargers. Contact Smith & Nephew, Inc. (Customer Care Center) at 1-800-876-1261 for for assistance.
Quantity in Commerce 2,550
Distribution Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.
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.
510(K) Database 510(K)s with Product Code = BTA and Original Applicant = BLUE SKY MEDICAL GROUP INCORPORATED
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