Events

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector 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
    56938
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0291-2011
  • 사례 출판 날짜
    2010-11-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95100
  • 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
    Implant, intragastric for morbid obesity - Product Code LTI
  • 원인
    The tubing strain relief component of the injection port may detach from the locking connector, and migrate from its original position on the locking connector. this may result in: tubing strain relief migrating on the tubing; kinking of the tubing resulting in difficulty/inability to adjust the fluid volume within the band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca.
  • 조치
    Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.

Device

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector
  • 모델명 / 제조번호(시리얼번호)
    Product Code RLZB22T, Lot #: G4RE82Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84 , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • 제품 설명
    REALIZE¿ Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84, , , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.
  • 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