Recall Z-0162-2009 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
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.
| Date | Oct 27, 2008 (initiated Aug 7, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042134 | VERSATILE 1 WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated, Nov 1, 2004 |