FDAFDA · Food and drugs·Recall number Z-0409-2013
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Published November 28, 2012 · Recall initiated: June 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KCI USA, Inc.
- Distributor
- Nationwide Distribution including AL, CA, CO, OK and GA.
- Lot
- Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.