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.
FDA Recall Z-0162-2009 · Posted 2008-10-27
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Recalling FirmSmith And Nephew, Inc. Wound Management Division
Recall StatusTerminated
Product CodeBTA
Date Initiated2008-08-07
Date Terminated2009-10-01
Product Quantity2,550
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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