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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 62852
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened. Product code KCT; Lot number: 60263 Class III On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators. 77 packs Z-2325-2012