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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Recall Number Z-2425-2012
Classification Class III
Code Info Product Code: 95221-35, Unit Code: 90372
Product Distributed Qty 32 cases
Reason For Recall The impacted product was not intended for commercial distribution to end users.

Event Detail

Event Id 62577
Product Type Devices
Status Completed
Recalling Firm Kimberly-Clark Corporation
City Roswell
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-12-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.