GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China. Indicated fo
FDA device recall Z-0162-2009 · posted 2008-10-27 · Terminated
Recall details
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BTA
- Quantity affected
- 2,550
- Distribution
- Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.
- Date initiated
- 2008-08-07
- Date posted
- 2008-10-27
- Date terminated
- 2009-10-01
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSATILE 1 WOUND VACUUM SYSTEM (K042134) | Blue Sky Medical Group Incorporated | 2004-11-01 |