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Terminated

FLEXICAIR MC3 Low Airloss Therapy unit

FDA Recall Z-0059-04 · Posted 2003-10-24

Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeIOQ
Date Initiated2003-08-27
Date Terminated2004-07-01
Product Quantity1824 units

Reason for Recall

Reports of patient entrapment between mattress and side-rails.

Firm Action

Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.

Root Cause

Other

Distribution Pattern

Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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