Events

Device Recall STERRAD 100S Cassette 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
    62925
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2337-2012
  • 사례 시작날짜
    2012-06-19
  • 사례 출판 날짜
    2012-09-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112044
  • 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
    Sterilizer, chemical - Product Code MLR
  • 원인
    Advanced sterilization products (asp) is recalling (removing) the sterrad 100s and sterrad nx system cassettes because the camera used to verify printing on the sterrad system cassettes was inadvertently disabled. the sterrad 100s and sterrad nx system cases were shipped without verification of proper printing.
  • 조치
    Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error. For the STERRAD 100S System cassettes, there is a chance that the barcode will be unreadable and the STERRAD 100S Sterilizer will not accept the cassette. Customers were instructed to complete and return the business reply card and packing slip that are included in the letter. Customers were instructed to contact Stericycle at (888) 406-9303 for additional labels. Customers with questions about the recall letter were instructed to contact Stericycle at (888) 406-9303.

Device

Device Recall STERRAD 100S Cassette
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 10113
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STERRAD 100S Cassette, Batch # 12A077. || The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA