Recall Z-0326-2017
Hill-Rom, Inc. · initiated August 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
Codes / lots: manufacturing date between Dec 01, 2015- Apr 14, 2016
Reason for recall
Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.
FDA-determined cause: Mixed-up of materials/components
Action taken
On 8/9/2016, URGENT: MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this Field Safety Correction, please contact Hill-Rom Technical Support at 1-800-445-3720, your distributor or your Hill-Rom representative.
Details
- Recall number
- Z-0326-2017
- Initiated
- August 9, 2016
- Posted by FDA
- October 31, 2016
- Terminated
- March 24, 2017
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Quantity
- 188
- Distribution
- WA NC OH PA MI Australia Sweden
- Recalling firm
- Hill-Rom, Inc., Batesville, IN