Events

Jackson Pratt" Channel drain 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Degania Silicone, Ltd. 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
    79199
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0899-2018
  • 사례 시작날짜
    2017-10-03
  • 사례 출판 날짜
    2018-02-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161625
  • 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
    Catheter, irrigation - Product Code GBX
  • 원인
    Sterile pouches are missing labels on them. the boxes themselves are properly labeled. the issue is related to the production lot p1607442 only.
  • 조치
    An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at Katia@ds-il.com.

Device

Jackson Pratt" Channel drain
  • 모델명 / 제조번호(시리얼번호)
    Lot No P1607442.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to Puerto Rico.
  • 제품 설명
    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. || Used for the drainage of body fluids for surgical use.
  • Manufacturer
    Degania Silicone, Ltd.

Manufacturer

Degania Silicone, Ltd.