Device Recall NOVAPLUS (TM), SUCTION CANISTER 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DeRoyal Industries 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
    56682
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0101-2011
  • 사례 시작날짜
    2010-07-01
  • 사례 출판 날짜
    2010-10-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-04-10
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • 원인
    Suction canisters may crack during use.
  • 조치
    DeRoyal sent a Recall letter dated July 1, 2010 to all their consignees via UPS Air. The letter identified the product, the problem, and action to be taken by the consignees. Consignees were to complete the Recall Response Form by checking their inventory for DeRoyal Suction Canisters V71-3001, Lot #22622679. Indicate the number of replacement products needed on the Recall Response Form, including the address, reference PO#, etc. to be used for the replacement products and fax the form to DeRoyal at 865-362-3755 no later than July 7, 2010. Recalled products were to be returned to DeRoyal via UPS Ground Attn: Quality Control 300 DeBusk Lane Powell, TN 37849 Once the recalled product was received by DeRoyal, the replacement product would be shipped per the instructions on the Recall Response Form. Distributors were to forward the recall notice to their end-users, or provide customer listing so that DeRoyal may contact them. For any questions or assistance regarding this recall call 865-362-1037.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 22622679
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 || Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.
  • Manufacturer

Manufacturer

  • 제조사 주소
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • 제조사 모회사 (2017)
  • Source
    USFDA