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Terminated

Reliance Synergy Washer/Disinfector

FDA Recall Z-1256-2022 · Posted None

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMEC
Date Initiated2022-04-22
Date Terminated2024-11-04
Product Quantity3,863 total units (2,776 US; 1,087 OUS)

Reason for Recall

The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Firm Action

On April 22, 2022, the firm distributed notification letters to affected customers. All affected customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) and perform the correction. Users may continue to use their affected devices prior to completion of the correction. Users are reminded to follow instructions outlined in the Operator Manual should the unit alarm "Drying Temperature Too High" by aborting the cycle, positioning building electrical disconnect switch to OFF, and contacting STERIS. If you have questions regarding this issue, please contact Sarah Brown, Senior Product Manager at 440-392-7571, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution - US Nationwide.

Official Source

View FDA Recall →

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

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