Recall Z-2659-2011 ยท ILO Pack, Hot Or Cold, Water Circulating
Pro Trainers' Choice Company
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankl
| Date | Jun 24, 2011 (initiated Apr 18, 2011) |
| Status | Terminated |
| Reason | The control panel of the Precision Ice One Patient Use Control Unit and Wrap System has a overheating issue. The control panel printed circuit boards were missing a jumper connection across resistors R28 A, B, C, and D. |
| Root cause | Other |
| Action | Pro Trainers' Choice sent a Mandate-Medical Device Recall on April 18, 2011 and April 20, 2011 to all affected costumers. The letter included a description of the product, affected model and lots. It instructed the costumers to discontinue using the Precision Ice, Model 4BBK02BK until the device is returned and corrected by Pro Trainers' Choice. The device should be returned to PO Box 27, Kingston, WA 98346. The customers were instructed to notify their sub-account customers of this recall if the devices were further distributed. Customers can call Pro Trainers' Choice Company at 360-297 |
| Quantity | 336 units |
| Distribution | Nationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.