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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Ice

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 Class 2 Device Recall Precision Icesee related information
Date Initiated by FirmApril 18, 2011
Date PostedJune 24, 2011
Recall Status1 Terminated 3 on March 01, 2012
Recall NumberZ-2659-2011
Recall Event ID 58770
Product Classification Pack (hot/cold) water circulating - Product Code ILO
ProductPrecision 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 ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***info@precisionice.com***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
Code Information The affected serial numbers range from 100116 to 100452.
Recalling Firm/
Manufacturer		 Pro Trainers' Choice Company
PO BOX 27
26129 Calvary Lane NE, Suite 200
Kingston WA 98346
For Additional Information Contact
360-297-3902
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionPro 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 360-297-3902 or visit the website www.precisionice.com for any questions about this recall.
Quantity in Commerce336 units
DistributionNationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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