GSK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GSK Consumer Healthcare 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
    74030
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2148-2016
  • 사례 시작날짜
    2016-04-25
  • 사례 출판 날짜
    2016-07-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-07-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Breathing - Nasal Strips - Product Code N/A
  • 원인
    Some cartons used in the secondary packaging of breathe right clear, large, 30 ct. nasal strips were incorrectly labeled for cartons intended for the au/nz market.
  • 조치
    GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.

Device

GSK
  • 모델명 / 제조번호(시리얼번호)
    Shipper case lot #8008580, Retal Carton Lot #4543U8008580
  • 유통
    US Nationwide
  • 제품 설명
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
  • Manufacturer

Manufacturer

  • 제조사 주소
    GSK Consumer Healthcare, 184 Liberty Corner Rd Ste 200, Warren NJ 07059-6868
  • 제조사 모회사 (2017)
  • Source
    USFDA