Recall Z-1254-2011 ยท IOQ Bed, Flotation Therapy, Powered
Hill-Rom Manufacturing, Inc.
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.
| Date | Feb 15, 2011 (initiated Dec 6, 2010) |
| Status | Terminated |
| Reason | Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used. |
| Root cause | Other |
| Action | Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the produ |
| Quantity | 42 Flexicair MC3 units |
| Distribution | Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863047 | FLEXICAIR Ssi Medical Services, Inc., Sep 5, 1986 |