Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0761-04

Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only

Hill-Rom Inc. / initiated 2004-03-15 / Terminated / root cause: labeling and UDI

Hill-Rom, Inc. began a recall of Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only on . The reason FDA records is "A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0761-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only.
Product code
LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Reason for recall
A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
A letter dated 3/15/04 was sent to each affected consignee, with labels included, requesting that they attach them to each affected bed.
Quantity in commerce
52
Distribution
Arizona, Florida, Georgia, Nevada, Puerto Rico, Texas, Virginia and Canada.
Product codes and lots
All remanufactured beds distributed between August 2003 and February 2004.