Device Recall FLEXICAIR MC3

All serial numbers. The prefix "IC" is representative of a Flexicair¿ MC3 and a six digit number without a prefix is representative of a refurbished Flexicair¿ MC3.

Physical Medicine Devices

2

No

Nationwide and Canada

Flexicair¿ MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.

Physical Medicine Devices

2

No

Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA

Flexicair¿ MC3 (Model number: M4000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.