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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Recall Number Z-2017-2012
Classification Class II
Code Info Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx.
Product Distributed Qty 79,941 units
Reason For Recall Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Event Detail

Event Id 62451
Product Type Devices
Status Terminated
Recalling Firm Kimberly-Clark Corporation
City Roswell
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-09-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA