Arthroscopy Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Customed, 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
    69448
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0274-2015
  • 사례 시작날짜
    2014-10-08
  • 사례 출판 날짜
    2014-12-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-08-14
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • 원인
    Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
  • 조치
    Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 140513063 140513390 140613948 140714429 140814966 140915118
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to Florida, New York and Puerto Rico..
  • 제품 설명
    Arthroscopy Pack, Catalog number 900-1062. || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 제조사 모회사 (2017)
  • Source
    USFDA