Z-1254-2011

Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development...

Name: Z-1254-2011 Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development...
Creator: Hill-Rom Manufacturing, Inc.
Published: 2010-12-06
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2010-12-06 / Terminated

FDA source

Hill-Rom Manufacturing, Inc. began a recall of Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have... on 2010-12-06. The reason FDA records is "Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1254-2011
Status: Terminated
Initiated: 2010-12-06
Posted: 2011-02-15
Terminated: 2011-11-01
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: 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.
Product code: IOQ Bed, Flotation Therapy, Powered
Reason for recall: Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
FDA 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 product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients. For questions regarding this recall call 800-445-3720.
Quantity in commerce: 42 Flexicair MC3 units
Distribution: Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
Product codes and lots: 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.

Product code IOQ

K863047Class IIFlexicairSsi Medical Services, Inc. / cleared 1986-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)