Events

Various DeRoyal Surgical Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DeRoyal 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
    72574
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0363-2016
  • 사례 시작날짜
    2015-09-10
  • 사례 출판 날짜
    2015-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141577
  • 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
    These custom sterile surgical kits contain the component, ecolab ors fluid warming and slush drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
  • 조치
    DeRoyal issued their recall on 09/10/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete. Hospitals were provided with labels to affix to the kits with the direction to discard the recalled component and notice of destruction forms to be completed and returned.

Device

Various DeRoyal Surgical Kits
  • 모델명 / 제조번호(시리얼번호)
    Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544;  Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in MO, MA, NC, CT, Kuwait.
  • 제품 설명
    DeRoyal sterile custom surgical kits: || 1) Emergency CABG Pack Pgybk, ref 89-7859.01 || 2) Emergency CABG Pack Pgybk, ref 89-7859.02 || 3) Open Heart Pack A&B; Pgybk, ref 89-7750.02 || 4) Open Heart Pack A&B; Pgybk, ref 89-7750.03 || 5) Intl-Cardiac Surgery Pack A&B; Pgybk, ref 89-8514.02 || GEO-MED sterile custom surgical kits: || 1) Open Heart Pack Pgybk, ref 89-5792.10 || 2) Open Heart A&B; Pgybk, ref 89-7626.02 || 3) Open Heart A&B; Pgybk, ref 89-7626.03 || 4) Open Heat Pack A&B; Pgybk, ref 89-8440.01 || 5) Open Heart Pack A&B; Pgybk, ref 89-8440.02
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • 제조사 주소
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • 제조사 모회사 (2017)
    Deroyal Industries Inc.
  • Source
    USFDA