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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

Product Description ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product 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-0257-2013
Classification Class II
Code Info Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
Product Distributed Qty 89,856 (28 units per case)
Reason For Recall Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Event Detail

Event Id 63598
Product Type Devices
Status Ongoing
Recalling Firm Kimberly-Clark Corporation
City Roswell
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution