Home / Recalls / KCI USA, Inc. / Z-0409-2013

Z-0409-2013 Class II Terminated

Recalled by KCI USA, Inc. — San Antonio, TX

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.

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