Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-99
FDA device recall Z-1777-2008 · posted 2008-08-27 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 69
- Distribution
- Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.
- Date initiated
- 2008-04-28
- Date posted
- 2008-08-27
- Date terminated
- 2009-09-22
- Location
- Batesville, IN
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