Events

Magic 3 Intermittent Catheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C.R. Bard, 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
    78642
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1308-2018
  • 사례 시작날짜
    2017-09-14
  • 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=161604
  • 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, straight - Product Code EZD
  • 원인
    Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Device

Magic 3 Intermittent Catheters
  • 모델명 / 제조번호(시리얼번호)
    Item # 50612 Lots #'s: JUBQ0995, JUAZ1253, JUBN0527, JUBP0065, JUBP0225, JUBP0675, JUBQ0093, JUBT1089, JUBQ1417, JUBQ1691, JUBR0232, JUAX0761, and JUAY0563 Item # 50614 Lots #'s: 53621355, JUAW0726, JUAW1103, JUAW1105, JUAW1200, JUAW1201, JUAW1209, JUAX0174, JUAX0275, JUAX0276, JUAX0679, JUAX0680, JUAX0745, JUAX0759, JUAY0141, JUAY0163,  JUAY0451, JUAY0468, JUAY0587, JUAY0655, JUAY0685, JUAY0911, JUAY0930, JUAZ0126, JUAZ0147, JUAZ1147, JUAZ1157, JUAZ1207, JUAZ1252, JUAZ1275, JUAZ1281, JUBN0049, JUBN0077, JUBN0490, JUBN0526, JUBN0824, JUBN0850, JUBN1022, JUBP0035, JUBP0063, JUBP0194, JUBP0224, JUBP0674, JUBP0699, JUBP1182, JUBP1202, JUBQ0024, JUBQ0039, JUBQ0076, JUBQ0091, JUBQ1023, JUBQ1390,  JUBQ1416, JUBQ1673, JUBQ1690, JUBR0256, JUBR0853, JUBR0883, JUBR1245, JUBR1271, JUBR2530, JUBR2531, JUBR2565, JUBS1262, JUBS1291, JUBS1877, JUBS1905, JUBS2411, JUBS2412, JUBS2449, JUBT1055 and JUBU0498 Item # 50616 Lot #'s: JUAX0175, JUAX0176, JUAX0177, JUAX0277, JUAX0681,  JUAX0708, JUAX0747, JUAY0142, JUAY0469, JUAY0588, JUAY0664, JUAY0931, JUAZ0148, JUAZ1148, JUAZ1208, JUBN0078, JUBN0491, JUBN0825, JUBN0851, JUBN0999, JUBN1023, JUBP0064, JUBP0701, JUBP1183, JUBP1203, JUBQ0092,J UBQ1024 , JUBQ1368, JUBQ1395,  JUBQ1686, JUBR0257, JUBR0373, JUBR0860, JUBR0890, JUBR1272, JUBS0439, JUBS0469, JUBS1263, JUBS2409, JUBS2410, JUBS2447,  JUBT0121, JUBT0161 and JUBT0162
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Hawaii and Puerto Rico
  • 제품 설명
    Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.