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Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinf

FDA device recall Z-2036-2014 · posted 2014-07-10 · Terminated

Recall details

Recalling firm
Steris Corporation
Reason for recall
STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.
Action taken
Customers will be notified via onsite visits by STERIS Field Service Technicians to each affected Customer site. These visits will be documented and monitored until completion.
Root cause
Device Design
Status
Terminated
Product code
MEC
Quantity affected
37
Distribution
US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.
Date initiated
2014-06-30
Date posted
2014-07-10
Date terminated
2015-07-01
Location
Mentor, OH

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