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.
FDA Recall Z-1777-2008 · Posted 2008-08-27
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2008-04-28
Date Terminated2009-09-22
Product Quantity69
Reason for Recall
A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
Firm 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.
Root Cause
Other
Distribution Pattern
Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.