MediVac NonConductive Suction Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    56563
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2455-2010
  • 사례 시작날짜
    2010-08-16
  • 사례 출판 날짜
    2010-09-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-11-28
  • 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
    Tubing, noninvasive - Product Code GAZ
  • 원인
    The packaging seals may not be intact, resulting in compromised sterility for the listed medi-vac non-conductive tubing.
  • 조치
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated August 16, 2010 to consignees, identifying the reason for the recall, the affected lots, and actions to be taken. Cardinal has inspected all packages in their warehouses and removed the affected products. All packages that have been inspected have a 3/4" green dot on the front of each unit and on the case carton label. " Cardinal Health end users were instructed to segregate and destroy their affected product and request credit or replacement " Distributor customers were instructed to destroy their product and request credit or replacement " Distributors were instructed to conduct sub-recalls and return their inventory to Cardinal Health " To arrange for credit or replacement of the product destroyed, the accounts were instructed to call customer service at 800-964-5227 or 888-444-5440. " All customers were requested to complete the enclosed Recall Acknowledgment Form acknowledging receipt of the letter and the number of tubing units destroyed, and fax it to 847-689-9101. Cardinal Health can be contacted at 800-292-9332. Cardinal sent recall letters dated 8/26/10 to their PreSource kit/module customers via UPS next day air, informing them that the Medi-Vac Non-conductive Suction Tubing listed may have packaging seals that are compromised. The accounts were informed that Cardinal has inspected tubing packages in their warehouses and removed the affected products. All packages that have been inspected will have a 3/4" green dot on the front of each package. Enclosed with the recall letter were recall labels to affix to each affected Presource pack/module in the account's inventory. These labels instruct the user NOT to use the affected tubing component and to remove and discard the component upon opening the kit. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of packs/modules on hand. Distributo

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots prior to Y10Kxxxx
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including USA.
  • 제품 설명
    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.6 m (12 ft.); Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N712 and NEX712 (European label)
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • 제조사 모회사 (2017)
  • Source
    USFDA