Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deter

FDA device recall Z-1253-2011 · posted 2011-02-15 · Terminated

Recall details

Recalling firm

Hill-Rom Manufacturing, Inc.

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Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IOQ

Quantity affected

1 Flexicair II unit

Distribution

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

Date initiated

2010-12-06

Date posted

2011-02-15

Date terminated

2011-11-01

Location

Charleston, SC

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