Events

Device Recall DeRoyal Surgical Kits and Trays 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
    62457
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2008-2012
  • 사례 시작날짜
    2012-06-16
  • 사례 출판 날짜
    2012-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110698
  • 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
    Surgical kits and trays contain stryker hytrel togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
  • 조치
    DeRoyal initiated the recall on 6/16/2012 by notifying customers by overnight delivery of letters describing the problem, instructing the customer how to handle inventory on hand, and requesting the customer to destroy the product, fill out the provided notice of destruction form, and return the form to DeRoyal. For questions customers were instructed to call 865-362-1020 or 865-362-1034. For questions regarding this recall call 865-362-2334.

Device

Device Recall DeRoyal Surgical Kits and Trays
  • 모델명 / 제조번호(시리얼번호)
    GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694   GEO-MED TOTAL HIP PACK, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including SD and NE.
  • 제품 설명
    Custom surgical kits and trays: || GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 || GEO-MED TOTAL HIP PACK, REF 89-6664.03 || surgical kits
  • 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