Recall Z-0409-2013— KCI USA, Inc.
Class II · Terminated
Class II FDA medical device recall by KCI USA, Inc., initiated 2012-06-27, terminated 2013-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- KCI USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-27
- Terminated
- 2013-04-22
- Firm location
- San Antonio, TX, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.