Events

Device Recall Catheter, C2 CryoBalloon Ablation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C2 Therapeutics, 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
    80180
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2256-2018
  • 사례 시작날짜
    2018-03-30
  • 사례 출판 날짜
    2018-06-05
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164786
  • 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
    The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. in this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
  • 조치
    On 3/30/2018, C2 Therapeutics issued URGENT FIELD CORRECTION notices to customers via certified mail, return receipt requested. Customers are advised to take the following Action: - Forward a copy of the notice and the enclosures to the department in which is referenced in the notice. - Inspect stock and quarantine products identified within the notice. - The end user of the affected products should complete and return the response form via email to RMA@c2therapeutics.com. The response form contains an RMA number to allow for the return of devices affected by this field action, and enclosed in the package is a Federal Express shipping label for the returned merchandise. Customers with questions can call 650-318-5899, Monday through Friday 8:30 AM - 5 PM, PST.

Device

Device Recall Catheter, C2 CryoBalloon Ablation System
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 02132018-01 & 02162018-03
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution US nationwide.
  • 제품 설명
    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
  • Manufacturer
    C2 Therapeutics, Inc.

Manufacturer

C2 Therapeutics, Inc.
  • 제조사 주소
    C2 Therapeutics, Inc., 303 Convention Way Ste 1, Redwood City CA 94063-1415
  • 제조사 모회사 (2017)
    HOYA Corp.
  • Source
    USFDA