FDA Recall Terminated

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.

Recall: Z-0162-2009 · Initiated August 7, 2008

Recall

Recall Number
Z-0162-2009
Event Number
49566
Firm
Smith And Nephew, Inc. Wound Management Division
FEI Number
3006760724
Product Code
BTA
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
August 7, 2008
Posted
October 27, 2008
Terminated
October 1, 2009
Address
11775 Starkey Road, Largo, FL, 33773-4727

Description

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.

Reason

External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.

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.

Distribution

Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.

Quantity

2,550