Events

PROXIMATE Skin Staple Extractor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon Endo-Surgery Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    64343
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0918-2013
  • 사례 시작날짜
    2012-10-04
  • 사례 출판 날짜
    2013-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115890
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Stapler, surgical - Product Code GAG
  • 원인
    Damage to the packaging may have compromised the sterility of the device.
  • 조치
    On 10/28/2012, the firm sent Urgent: Device Recall, Event 5928 notification letters to their customers. The letters identified the affected product, the reason for the recall, the action to be taken by customers, as well as the actions taken by the firm. Customers are to examine their inventory immediately and remove the affected product. The Business Reply Form should be completed and faxed to Stericycle at 1-877-650-0360 within 3 business days, even if there is no affected product on hand. Customers must complete the "Replacement Purchase Order Number Field" on the Business Reply Form to ensure adequate identification of the return product in their facility. Customers should follow the instructions provided in order to return the product. The information should be shared with all appropriate staff at the customer's facility. EES planned to replace any unopened an unexpired recall product that was returned by December 31, 2012. Questions regarding the issue should be directed to Stericycle at 1-877-650-5412.

Device

PROXIMATE Skin Staple Extractor
  • 모델명 / 제조번호(시리얼번호)
    Expiration dates: September 2012 - August 2017
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    PSX PROXIMATE Skin Staple Extractor, || ETHICON ENDO-SURGERY, LLC. || For routine skin closure in a wide variety of surgical procedures.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • 제조사 주소
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA