Events

Tenaxis Medical ArterX(TM) Surgical Sealant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mallinckrodt Manufacturing LLC 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
    77482
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2687-2017
  • 사례 시작날짜
    2014-10-17
  • 사례 출판 날짜
    2017-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156110
  • 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
    Sealant,polymerizing - Product Code NBE
  • 원인
    Product was improperly labeled leading to improper storage.
  • 조치
    The direct consignee was notified by email on October 17, 2014. The action requested to be taken on receipt of the notice: " Remove all ArterX delivered by CJ Medical from inventory and quarantine for return to CJ Medical. " Return the product to CJ Medical for a credit or product replacement " If no ArterX is found in inventory, please comment to that effect on the attached form and return the form to CJ Medical. The consignee was also requested to circulate the Field Safety Notice among all users affected by this product. For further questions, please call (314) 654-2000.

Device

Tenaxis Medical ArterX(TM) Surgical Sealant
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution to the country : UK
  • 제품 설명
    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC || Adjunct to sutures in vascular surgery.
  • Manufacturer
    Mallinckrodt Manufacturing LLC

Manufacturer

Mallinckrodt Manufacturing LLC
  • 제조사 주소
    Mallinckrodt Manufacturing LLC, 835 Maude Ave, Mountain View CA 94043-4021
  • 제조사 모회사 (2017)
    Mallinckrodt Plc
  • Source
    USFDA