Recall Z-1253-2011
Hill-Rom Manufacturing, Inc. · initiated December 6, 2010
Product
Flexicair II (Model number 13000) 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.
Codes / 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.
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Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.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: Other
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.
Details
- Recall number
- Z-1253-2011
- Initiated
- December 6, 2010
- Posted by FDA
- February 15, 2011
- Terminated
- November 1, 2011
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Quantity
- 1 Flexicair II unit
- Distribution
- Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
- Recalling firm
- Hill-Rom Manufacturing, Inc., Charleston, SC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1254-2011 | Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent…Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to… | 12/06/2010Terminated |