Events

Celerity PICC Tip Confirmation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics Inc. (Navilyst Medical 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
    75226
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1137-2017
  • 사례 시작날짜
    2016-09-07
  • 사례 출판 날짜
    2017-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149720
  • 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
    Tracheotome - Product Code LJW
  • 원인
    The celerity ecg cable accessory pack has the potential to contain an ecg clip cable that was not properly manufactured. the affected product is not soldered per specification, and may result in the device not properly conducting the ecg signal.
  • 조치
    On 9/7/2016, AngioDynamics, Inc. sent URGENT VOLUNTARY MEDICAL DEVICE RECALL Notifications (dated 9/7/2016) to 47 consignees via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics and complete and return the Reply Verification Tracking Form, provided in the recall notification. Please call AngioDynamics Customer Service at 1-800-772-6446 Monday - Friday between 8:00 am and 7:00 Pm EST to obtain a replacement or credit for returned product.

Device

Celerity PICC Tip Confirmation System
  • 모델명 / 제조번호(시리얼번호)
    AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D; medCOMP UPN MRLCA000, Batch/Lot Number MBVT240.
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
  • 제품 설명
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • 제조사 주소
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA