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U.S. Department of Health and Human Services

Class 2 Device Recall Flexicair MC3

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  Class 2 Device Recall Flexicair MC3 see related information
Date Initiated by Firm December 06, 2010
Date Posted February 15, 2011
Recall Status1 Terminated 3 on November 01, 2011
Recall Number Z-1254-2011
Recall Event ID 57592
510(K)Number K863047  
Product Classification Bed, flotation therapy, powered - Product Code IOQ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information Contact Robert Farley
843-740-8586
Manufacturer 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for Recall		 Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IOQ and Original Applicant = SSI MEDICAL SERVICES, INC.
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