Events

Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    56367
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1393-2011
  • 사례 시작날짜
    2010-06-23
  • 사례 출판 날짜
    2011-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93317
  • 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
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - Product Code KCT
  • 원인
    The recall was initiated after advanced sterilization products (asp) discovered a non-conforming lot. the misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.
  • 조치
    Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.

Device

Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 2020
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.
  • 제품 설명
    Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. || Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA