Reported Nov 28, 2012 · Terminated
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of…
KCI USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KCI USA, Inc. · 4958 Stout Dr · San Antonio, TX · 78219-4334
Is this the product you have?
- RotoRest Delta
- Kinetic Therapy System INDICATIONSTreatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
- Lot codes and dates
- Model Number 208030
- Serial Numbers
0015708700157091001572880015737500157405RRCKOO011RRHKOO065RRHKOO074RRHKOO096RRHK00109and RRHKOO117
- Amount recalled
- 282 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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