Events

Device Recall MAJOR LAP 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
    71721
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2673-2015
  • 사례 시작날짜
    2015-07-10
  • 사례 출판 날짜
    2015-09-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139052
  • 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
    General surgery tray (kit) - Product Code LRO
  • 원인
    Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
  • 조치
    Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Device

Device Recall MAJOR LAP PACK
  • 모델명 / 제조번호(시리얼번호)
    Code:900404 Lots: 140915488 exp. 10/31/15 141216330 exp. 12/31/15 141216438 exp. 12/31/15 141216438 exp. 12/31/15 150116533 exp. 2/28/16 150116807 exp. 2/28/16 150116808 exp. 2/28/16 150116809 exp. 2/28/16 150116810 exp. 2/28/16 150116811 exp. 2/28/16 150217401 exp. 2/28/16 150217402 exp. 2/28/16 150217404 exp. 2/28/16 150217405 exp. 2/28/16 150217403 exp. 2/28/16 150217406 exp. 2/28/16 150217407 exp. 2/28/16 150217408 exp. 2/28/16 150217409 exp. 2/28/16 150317803 exp. 3/31/16 150317805 exp. 3/31/16 150317808 exp. 3/31/16 150317807 exp. 3/31/16 150317809 exp. 3/31/16 150317806 exp. 3/31/16 150418397 exp. 4/30/16 150418398 exp. 4/30/16 150418399 exp. 4/30/16 150418400 exp. 4/30/16 150418499 exp. 4/30/16 150418500 exp. 4/30/16 150418501 exp. 4/30/16 150418498 exp. 4/30/16 150519002 exp. 5/31/16 150519004 exp. 6/30/16 150519003 exp. 6/30/16 150519005 exp. 6/30/16 150619464 exp. 6/30/16 150619463 exp. 6/30/16 150619385 exp. 6/30/16 150619466 exp. 6/30/16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    MAJOR LAP PACK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc

Manufacturer

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