Z-0162-2009

GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China...

Name: Z-0162-2009 GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China...
Creator: Smith And Nephew, Inc. Wound Management Division
Published: 2008-08-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-08-07 / Terminated / root cause: manufacturing process

FDA source

Smith And Nephew, Inc. Wound Management Division began a recall of 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... on 2008-08-07. The reason FDA records is "External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0162-2009
Status: Terminated
Initiated: 2008-08-07
Posted: 2008-10-27
Terminated: 2009-10-01
Recalling firm: Smith & Nephew, Inc.
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.
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Product code BTA

K042134Class IIVersatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated / cleared 2004-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)