Events

Device Recall CIVCO SurgiTip Transducer cover 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Civco Medical Instruments 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
    56285
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2242-2010
  • 사례 시작날짜
    2010-07-20
  • 사례 출판 날짜
    2010-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93139
  • 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
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • 원인
    Polyethylene material did not have proper treatment applied during manufacturing. untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
  • 조치
    CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.

Device

Device Recall CIVCO SurgiTip Transducer cover
  • 모델명 / 제조번호(시리얼번호)
    Lot M538160
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
  • 제품 설명
    CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • 제조사 주소
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • 제조사 모회사 (2017)
    Roper Technologies Inc
  • Source
    USFDA