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Terminated

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.

FDA Recall Z-0326-2017 · Posted 2016-10-31

Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2016-08-09
Date Terminated2017-03-24
Product Quantity188

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.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

WA NC OH PA MI Australia Sweden

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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