Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.

FDA device recall Z-1874-2009 · posted 2009-08-03 · Terminated

Recall details

Recalling firm

Hill-Rom Manufacturing, Inc.

Reason for recall

The devices may emit smoke from the blower box assembly.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

IOQ

Quantity affected

57 units

Distribution

Nationwide and Canada

Date initiated

2009-05-12

Date posted

2009-08-03

Date terminated

2012-04-03

Location

Charleston, SC

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