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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Recall Number Z-0746-2014
Classification Class II
Code Info not available
Product Distributed Qty 2366 units
Reason For Recall Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Event Detail

Event Id 67043
Product Type Devices
Status Ongoing
Recalling Firm Advanced Sterilization Products
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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