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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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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
Distribution Pattern US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product Code: 95221-35, Unit Code: 90372 Class III The impacted product was not intended for commercial distribution to end users. 32 cases Z-2425-2012