Device recall

Z-2659-2011: Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK)…

FDA device recall · Class II · Pro Trainers' Choice Company

Key facts

Recall number (Z-number) Z-2659-2011
Recall event 58770
Product 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…
Product code ILO
Recalling firm Pro Trainers' Choice Company
Recall class Class II
Status Terminated
Termination date Mar 1, 2012
FEI number 3004733525

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)