Events

17G Cryoablation Needle Holder 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Galil Medical, 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
    61657
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1613-2012
  • 사례 시작날짜
    2012-04-12
  • 사례 출판 날짜
    2012-05-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108652
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • 원인
    Galil medical is recalling 17g cryoablation needle holder, fprpr 4014. this voluntary recall has been initiated due to the possibility of excessive bioburden on the needle holders.
  • 조치
    Galil Medical sent an "Urgent Medical Device Recall" letter dated April 12, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken. The letter instructs customers to return all unused affected products, use a revised needle preparation procedure and forward and communicate this Recall Notice and instructions. Customers were instructed to complete and return the attached Response Form with returned product or fax to 1+877-510-7757. For any questions contact Galil Medical Customer Service.

Device

17G Cryoablation Needle Holder
  • 모델명 / 제조번호(시리얼번호)
    N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002; N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008; N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003; N7729-004; N7890-001; N7890-002 ; N7975-004;N7975-005
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of CA, NY, NC, WA and the countries of CANADA, DENMARK, FRANCE, NETHERLANDS, TAIWAN and UNITED KINGDOM.
  • 제품 설명
    Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. || Product Usage: || Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.
  • Manufacturer
    Galil Medical, Inc.

Manufacturer

Galil Medical, Inc.
  • 제조사 주소
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • 제조사 모회사 (2017)
    Btg Plc
  • Source
    USFDA