Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likoral

FDA device recall Z-0326-2017 · posted 2016-10-31 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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.

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

FSA

Quantity affected

188

Distribution

WA NC OH PA MI Australia Sweden

Date initiated

2016-08-09

Date posted

2016-10-31

Date terminated

2017-03-24

Location

Batesville, IN