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.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
