Events

Device Recall Compat Nasogastric Feeding Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nestle HealthCare Nutrition 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
    65781
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1922-2013
  • 사례 시작날짜
    2013-07-24
  • 사례 출판 날짜
    2013-08-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120128
  • 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
    Tube, feeding - Product Code FPD
  • 원인
    Nestle healthcare nutrition, inc. is initiating a recall on some of compat ng tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
  • 조치
    Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form. For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.

Device

Device Recall Compat Nasogastric Feeding Tube
  • 모델명 / 제조번호(시리얼번호)
    REF 08310400 - Compat¿ Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G  02412K 08211Z 08712W 14212U 14611P 21512Y 35411H  REF 08310500- Compat¿ Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N  04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U  REF 08310600 - Compat¿ Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
  • 제품 설명
    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). || Product Usage: || The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
  • Manufacturer
    Nestle HealthCare Nutrition

Manufacturer

Nestle HealthCare Nutrition
  • 제조사 주소
    Nestle HealthCare Nutrition, 12500 Whitewater Dr, Minnetonka MN 55343-9420
  • 제조사 모회사 (2017)
    Nestlé S.A.
  • Source
    USFDA