Hill-Rom Manufacturing, Inc. Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
Brand
Hill-Rom Manufacturing, Inc.
Lot Codes / Batch Numbers
where "xxxxxx" is a six digit number. The prefix "IB" is representative of a Flexicair¿ II.
Products Sold
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.
Hill-Rom Manufacturing, Inc. is recalling Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores. due to The devices may emit smoke from the blower box assembly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices may emit smoke from the blower box assembly.
Recommended Action
Per FDA guidance
Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair II and Flexicair MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026