Events

Device Recall AMT Bridle Nasal Tube Retaining System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Applied Medical Technology 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
    76264
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1223-2017
  • 사례 시작날짜
    2017-01-19
  • 사례 출판 날짜
    2017-02-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152603
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • 원인
    Expired expiration dates are listed on the pouches.
  • 조치
    Applied Medical Technology Inc. sent an Urgent Medical Device Recall letter dated January 19, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Applied Medical Technology requests that customers IMMEDIATELY TAKE THE ACTION and return all devices in inventory subject to this recall. Do not use any device subject to this recall. Complete and return to Applied Medical Technology the enclosed RECALL NOTIFICATION. For further questions please call (440) 717- 4000.

Device

Device Recall AMT Bridle Nasal Tube Retaining System
  • 모델명 / 제조번호(시리얼번호)
    Table 1: 4-4108M  Box P/N - 4-4108M  Box Lot Number - 161018-193  Box Exp. - 2019-09-01 Box UDI - (01)00842071106638(17)190901(10)161018-193  Pouch P/N - E4-4108M  Pouch Lot Number - 160930-186  Pouch Exp. - 2010-09-01  Pouch UDI - (01)00842071103934(17)100901(10)160930-186   Table 2: 4-4110  Box P/N - 4-4110  Box Lot Number - 161014-166 Box Exp. - 2019-10-01 Box UDI - (01)00842071106645(17)191001(10)161014-166  Pouch P/N - E4-4110 Pouch Lot Number - 161010-090  Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103941(17)101001(10)161010-090   Table 3: 4-4114 Box P/N - 4-4114  Box Lot Number - 161021-139  Box Exp. - 2019-09-01 Box UDI - (01)00842071106669(17)190901(10)161021-139  Pouch P/N - E4-4114 Pouch Lot Number - 160926-242  Pouch Exp. - 2010-09-01 Pouch UDI - (01)00842071103965(17)100901(10)160926-242   Table 4: 4-4116 Box P/N - 4-4116 Box Lot Number - 161019-105  Box Exp. - 2019-09-01 Box UDI - (01)00842071106676(17)190901(10)161019-105  Pouch P/N - E4-4116  Pouch Lot Number - 161007-038  Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103972(17)101001(10)161007-038
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : AZ, CA, CO, CT, FL, GA, ID, LA, ME, MO, MN, NC, OH, OK, OR, TN, TX, UT, WA, and WI., and to the United Kingdom.
  • 제품 설명
    AMT Bridle - Nasal Tube Retaining System || Used with Nasogastric/Nasointestinal (NG/NI) tubes.
  • Manufacturer
    Applied Medical Technology Inc

Manufacturer

Applied Medical Technology Inc
  • 제조사 주소
    Applied Medical Technology Inc, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • 제조사 모회사 (2017)
    Applied Medical Technology Inc.
  • Source
    USFDA