Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1090-04

Hill-Rom brand TotalCare Bed System; Model P1900

Hill-Rom Inc. / initiated 2004-06-28 / Terminated / root cause: labeling and UDI

Hill-Rom, Inc. began a recall of Hill-Rom brand TotalCare Bed System; Model P1900 on . The reason FDA records is "An incorrect warning label was placed on these beds. Warning should say, "do not use for life sustaining equipment....."". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1090-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom brand TotalCare Bed System; Model P1900.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
An incorrect warning label was placed on these beds. Warning should say, "do not use for life sustaining equipment....."
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Letters dated June 28, 2004 were sent to each consignee informing them of the problem and that Hill-Rom will inspect and verify the correct warning label is present.
Quantity in commerce
180
Distribution
Nationwide and Canada.
Product codes and lots
All beds built during April and May of 2004.