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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description PROXIMATE® Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC Guaynabo, Puerto Rico 00969 USA Assembled in Mexico. For routine skin closure in a wide variety of surgical procedures.
Recall Number Z-0918-2013
Classification Class II
Code Info Expiration dates: September 2012 - August 2017
Product Distributed Qty 5,894,975 pieces
Reason For Recall Ethicon Endo-Surgery initiated a voluntary recall for all PSX Proximate® Skin Staple Extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device.

Event Detail

Event Id 64343
Product Type Devices
Status Ongoing
Recalling Firm Ethicon Endo-Surgery Inc
City Cincinnati
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.
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