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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 61974
Product Type Devices
Status Ongoing
Recalling Firm Getinge USA Inc
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128 Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952 Class II Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error. 8 washers Z-2079-2012
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