Events

Device Recall Microcyn Dermatology HydroGel Spray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Oculus Innovative Sciences 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
    60387
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0451-2012
  • 사례 시작날짜
    2011-11-09
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105232
  • 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
    Dressing, wound,drug - Product Code FRO
  • 원인
    Unapproved drug claims and those not approved under 510k clearance.
  • 조치
    Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.

Device

Device Recall Microcyn Dermatology HydroGel Spray
  • 모델명 / 제조번호(시리얼번호)
    Part number: 84811 - 1.76 oz. Lot numbers: 10C0030-03, exp 3/12; 10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01, exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12; 11B0051-01, exp 2/13.  Part number 84828, 4 oz. lot 10C0032, exp 3/12.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. || Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. || Antibiotic-free, steroid-free and biodegradable.. || Oculus Innovative Sciences . || Petaluma, CA 94954. || Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
  • Manufacturer
    Oculus Innovative Sciences Inc

Manufacturer

Oculus Innovative Sciences Inc
  • 제조사 주소
    Oculus Innovative Sciences Inc, 1129 N Mcdowell Blvd, Petaluma CA 94954-1110
  • 제조사 모회사 (2017)
    Sonoma Pharmaceuticals Inc.
  • Source
    USFDA