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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