Device Recall Equate MutiPurpose Solution, For Soft Contact Lenses, Sterile 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bausch & Lomb 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
    59525
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-3042-2011
  • 사례 시작날짜
    2011-06-30
  • 사례 출판 날짜
    2011-08-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-11-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
  • 원인
    Muti-purpose solution bottles, lot gc1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
  • 조치
    Bausch & Lomb Inc. notified the affected customer via teleconference and e-mail on June 30, 2011. The e-mail describes the product, problem, and actions to be taken by the customer. The customer was instructed to hold and stop shipments of any inventory of the affected product. An official recall was initiated with the customer on July 8, 2011 via e-mail and teleconference. Customer was asked to review their inventory and store returns, and send any of the affected product to Bausch & Lomb Returns Dept., 130 Commerce Drive, Greenville, SC 29615.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot number: GC1107
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution-in the state of AK only
  • 제품 설명
    Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716 || Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA