Events

Device Recall Unifine Pentips 5mm x 31G pen needles 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Owen Mumford USA, 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
    78483
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0382-2018
  • 사례 시작날짜
    2017-11-06
  • 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=160457
  • 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
    Device may potentially be compromised by water in end user packaging. exposure to liquid may compromise sterility. this may appear as discoloring or yellowing of the device's protective seal.
  • 조치
    Owen Mumford sent an Urgent Medical Device Recall Notification letter dated November 6, 2017 via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check inventory for affected product, contact the Customer Service Department to arrange return of affected product, complete and return the response form and to either provide a customer list for Owen and Mumford to notify their customers or confirmation that they will notify their customers if further distributed.

Device

Device Recall Unifine Pentips 5mm x 31G pen needles
  • 모델명 / 제조번호(시리얼번호)
    UPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
  • 제품 설명
    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. || Product Usage: || Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
  • Manufacturer
    Owen Mumford USA, Inc.

Manufacturer

Owen Mumford USA, Inc.
  • 제조사 주소
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • 제조사 모회사 (2017)
    Owen Mumford Holdings Limited
  • Source
    USFDA