FDAFDA · Food and drugs·Recall number Z-0918-2013
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Published March 13, 2013 · Recall initiated: October 4, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Damage to the packaging may have compromised the sterility of the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo-Surgery Inc
- Distributor
- 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.
- Lot
- Expiration dates: September 2012 - August 2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.