Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1777-2008

Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12...

Hill-Rom Inc. / initiated 2008-04-28 / Terminated

Hill-Rom, Inc. began a recall of Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41... on . The reason FDA records is "A risk of entrapment will exist between the head and foot rails if installation instructions are followed". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1777-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
FDA root cause
Other
Action
Hill-Rom issued an Urgent Medical Device Correction letter on 4/28/2008 notifying consignees that they will be visited by a qualified Hill-Rom service technician or designee and provide a revised copy of the instruction sheet. The technician will either assist the facility to ensure proper installation or verify by signature that the facility understands the issue and will verify their beds had the upgrade kits installed in such a way that an entrapment gap does not exist.
Quantity in commerce
69
Distribution
Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.
Product codes and lots
All MOD 376 HBSW Siderail Upgraded accessory kits shipped between 9/19/06 and 3/18/07. Accessory kits do not bear serial numbers.