Z-0409-2013 Class II Terminated
FDA device recall Z-0409-2013 was initiated by KCI USA, Inc. on June 27, 2012 and is designated Class II. 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… The recall status is terminated (terminated April 22, 2013). Affected quantity: 282 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- June 27, 2012
- Termination Date
- April 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 282 units
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.
Distribution Pattern
Nationwide Distribution including AL, CA, CO, OK and GA.
Code Information
Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.