Events

Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Action Industries 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
    80147
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2043-2018
  • 사례 시작날짜
    2017-12-11
  • 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=164683
  • 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
    Fiber, medical, absorbent - Product Code FRL
  • 원인
    Product sterility potentially compromised.
  • 조치
    On December 11, 2017, the firm sent letters to their consignee informing them to: Immediately examine your inventory and quarantine all product subject to this recall notification. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Replacement product should be available within the next two weeks. Should you have immediate replacement needs in the interim, we do have sufficient inventory of AVID265, Blue OR Towel Non X-Ray Detectable (4 Towels per Pack), available for immediate distribution. Your assistance is appreciated and necessary to prevent any unintended use of affected product. Please complete and return the enclosed response form as soon as possible. For further questions, please call (828_ 338-7604.

Device

Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack)
  • 모델명 / 제조번호(시리얼번호)
    Item Code #AVID266, Lot No. 231479, Exp. Date 08/31/2021 and Item Code #AVID266, Lot No. 232564, Exp. Date 11/06/2021.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
  • 제품 설명
    Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile || This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • 제조사 주소
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • 제조사 모회사 (2017)
    Owens & Minor Inc
  • Source
    USFDA