Events

Device Recall Axillent Debakey Grasping Forceps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Karl Storz Endoscopy America 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
    66823
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0465-2014
  • 사례 시작날짜
    2013-11-06
  • 사례 출판 날짜
    2013-12-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123575
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • 원인
    Karl storz is recalling the axillent debakey grasping forceps because the 33821wtd wavy grasper was mislabeled as 33821dyd axillent debakey grasping forceps.
  • 조치
    Karl Storz Endosocopy sent a Safety Alert letter dated November 6, 2013, to all customers who received the 33821DYD Axillent Debakey Grasping Forceps. The letter informed the customers of the problems identified and the actions to be taken. Customers were asked to set aside the mislabeled product and return the mislabeled instruments with the RMA (Return Material Authorization) number issued to them. Customers were instructed to fax or email completed recall response form to (424) 218-8519. Customers with any questions were instructed to call (800) 421-0837 ext 8289. For questions regarding this recall call 746-708-8440.

Device

Device Recall Axillent Debakey Grasping Forceps
  • 모델명 / 제조번호(시리얼번호)
    Lot Code YX
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including states of: TX, PA, and NY.
  • 제품 설명
    Axillent Debakey Grasping Forceps, Part No. 33821DYD || In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • 제조사 주소
    Karl Storz Endoscopy America Inc, 15 Wells St, Southbridge MA 01550-4503
  • 제조사 모회사 (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA