Events

Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution 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
    72098
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0240-2016
  • 사례 시작날짜
    2015-08-31
  • 사례 출판 날짜
    2015-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139865
  • 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
    Custom sterile surgical kits contain 3m duraprep (tm) surgical solution, catalog number 8630, lot number 2016-09ee which was recalled due to unintended exposure to the sterilant during package sterilization.
  • 조치
    DeRoyal initiated their recall on 08/31/2015 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 and return the spreadsheet of how many they labeled. They were asked to return the spreadsheet even if they did not have inventory. Hospitals were provided with labels to affix to the kits with direction to discard the recalled component and notice of destruction forms to be completed and returned.

Device

Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution
  • 모델명 / 제조번호(시리얼번호)
    REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177;  REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    SC, FL, OH, NJ, OK, MN, AR
  • 제품 설명
    DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: || TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; || KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; || TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; || PACEMAKER PACK, REF 89-8381.01;
  • 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