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.
This recall has been terminated (originally issued August 27, 2008).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- April 28, 2008
- Posted
- August 27, 2008
- Terminated
- September 22, 2009
- Recall Number
- Z-1777-2008
- Quantity
- 69
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
Reason for Recall
A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
Distribution
Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.
Lot / Code Info
All MOD 376 HBSW Siderail Upgraded accessory kits shipped between 9/19/06 and 3/18/07. Accessory kits do not bear serial numbers.
Root Cause
Other
Action Taken
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.