Device Recall CaviCide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Metrex Research, LLC. 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
    62864
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2267-2012
  • 사례 시작날짜
    2012-02-06
  • 사례 출판 날짜
    2012-08-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-08-24
  • 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
    Disinfectant, medical devices - Product Code LRJ
  • 원인
    Metrex research is recalling cavicide containing the spring fresh fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort.
  • 조치
    Metrex sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Mandatory Recall Response Form was attached for customers to complete and return via fax to 734-947-6725. Contact Customer Care Center at (800) 841-1428 for questions regarding this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    CaviCide Lot # 10-1301, 10-2301, 10-2302, 10-2328, 10-2328A, 10-2328B, 10-2331, 10-2333, 10-1334, 10-2334, 10-1335, 10-2335, 10-1342A, 10-1343, 10-2345.  EnviroCide Lot # 10-2331.  Backscratchers Cavicide lot # 10-1342.  MaxiSpray Plus lot # 10-2328A and 10-1343.  pdCARE Surface Disinfectant lot # 10-2331 and 10-2345.  Z3 Surface Disinfectant lot # 10-2328.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
  • 제품 설명
    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. || Alternate brands: || EnviroCide, part number: 13-3325. || Private labeled products of Cavicide: || Backscratchers Cavicide, part number: 13-4800. || MaxiSpray Plus, part numbers: 13-7400 and 13-7405. || pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. || Z3 Surface Disinfectant, part number: 13-7900. || CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • 제조사 모회사 (2017)
  • Source
    USFDA