Device Recall Bard(R) Infant Feeding Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C.R. Bard, 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
    79507
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1355-2018
  • 사례 시작날짜
    2018-02-27
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Tube, feeding - Product Code FPD
  • 원인
    Bmd has identified that the product code/lot number combination identified above may have ineffectively fused tubing and enfit(tm) connector.
  • 조치
    The firm initiate their recall by letter on 02/27/2018 by letter. The recall letter stated: "Action required: " Immediately examine your inventory and quarantine product subject to this recall. Please refer to the sample product labeling on Attachment 1 to help you locate the product. Do not use or further distribute any affected product. " Please complete and return the accompanying Recall & Effectiveness Check Form attached to this letter regardless of whether or not you have any of the affected product. Additional instructions for product return are contained on the form. Upon receipt of the form indicating there is product to return, the BMD Recall Coordinator will issue you a return authorization number for return of the affected product. " If you have further distributed any units from the affected lots, please identify your customers and notify them at once of this product recall by forwarding a copy of this letter. Your notification should include a copy of this letter and the accompanying enclosures. This recall should be carried out to the user level."

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: NGARX207, NGAX3462
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 || Product Usage: || BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
  • Manufacturer

Manufacturer