Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1482-04

Hill-Rom brand VersaCare Bed; Model P3200

Hill-Rom Inc. / initiated 2004-08-24 / Terminated / root cause: labeling and UDI

Hill-Rom, Inc. began a recall of Hill-Rom brand VersaCare Bed; Model P3200 on . The reason FDA records is "Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1482-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom brand VersaCare Bed; Model P3200.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Recall letters dated August 24, 2004 were sent to consignees advising them to inspect and monitor the beds until Hill-Rom can visit and make corrections.
Quantity in commerce
5048
Distribution
Nationwide, Brazil, Canada, Hong Kong and United Arab Emirates.
Product codes and lots
All units.