FDA Medical Device Recalls (openFDA)
Smith And Nephew, Inc. Wound Management Division: 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 number
- Z-0162-2009
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division
- 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.
- Status
- Terminated
- Initiated
- 2008-08-07
- Posted
- 2008-10-27
- Terminated
- 2009-10-01
- Reason
- 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
- 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
- 2,550
- Distribution
- Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K042134"]
- PMA numbers
- not on file
- Product code
- BTA
- Firm FEI
- 3006760724
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28