Events

Winged Infusion Sets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems, 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
    27431
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0098-04
  • 사례 시작날짜
    2003-09-23
  • 사례 출판 날짜
    2003-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-03-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29865
  • 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
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • 원인
    Sterility of product is compromised by open seals in packaging.
  • 조치
    Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.

Device

Winged Infusion Sets
  • 모델명 / 제조번호(시리얼번호)
    Product Code 0603300 Gauge size 20 needle length 1.5'' Lot # 22FN4059; Product Code 0604190 Gauge Size 20 Needle Length 0.75'' Lot # 22FN4062; Product Code 0604200 Gauge Size 20 Needle Length 1.0'' Lot # 22KM1206, # 22KM1209, # 22KM1220; Product Code 0604210 Gauge Size 22 Needle Length 0.75'' Lot # 22KM1207; Product Code 0604220 Gauge Size 22 Needle Length 1.0'' Lot # 22KM1210; Product Code 0604270 Gauge Size 20 needle Length 0.5'' Lot # 22KM1211; Product Code 2205220 Gauge Size 20 Needle Length 0.75''  Lot # 22KM1213, # 22KM1214, # 22KM1215,   # 22KM1216, # 22KM1217, #22KM1222,   # 22KM1223, # 22KM1224, # 22KMX222,   # 22KMX223, # 22KMX224, # 22FN4057;  Product Code 2205222, Gauge Size 22 Needle Length 0.75'', Lot # 22FN4056;  Product Code 2206219 Gauge Size 19 Needle Length 1.0'', Lot # 22KM1218, # 22KM1219; Product Code 2206220, Gauge size 19 Needle Length 1.0'', Lot # 22KM1225, # 22KM1219.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.
  • 제품 설명
    Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
  • Manufacturer
    Bard Access Systems, Inc

Manufacturer

Bard Access Systems, Inc
  • 제조사 주소
    Bard Access Systems, Inc, 5425 W Amelia Earhart Dr, Salt Lake City UT 84116
  • Source
    USFDA