Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0326-2017Class II

Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall...

Hill-Rom Inc. / initiated 2016-08-09 / Terminated

Hill-Rom, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0326-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
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.
Product code
FSA Lift, Patient, Non-Ac-Powered
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 root cause
Mixed-up of materials/components
Action
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.
Quantity in commerce
188
Distribution
WA NC OH PA MI Australia Sweden
Product codes and lots
manufacturing date between Dec 01, 2015- Apr 14, 2016

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0326-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0326-2017Class IITerminatedVoluntary: Firm initiated