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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Product Detail

Product Description 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.
Recall Number Z-2325-2012
Classification Class III
Code Info Product code KCT; Lot number: 60263
Product Distributed Qty 77 packs
Reason For Recall 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.

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 Letter
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.