Device Recall BARD Biopsy Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Peripheral Vascular 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
    64276
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1527-2013
  • 사례 시작날짜
    2013-01-23
  • 사례 출판 날짜
    2013-06-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Marker, radiographic, implantable - Product Code NEU
  • 원인
    Bard peripheral vascular (bpv) is initiating this recall because a combination of bard¿ ultraclip¿ dual trigger tissue marker's and support catheters (microsheath and usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
  • 조치
    The firm, BARD Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter on January 23, 2013, to its customers. Bard EXPANDED its recall to include (MicroSheath and Usher support Catheters) and sent another "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 5, 2013 describing the additional products, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Do not use or further distribute any affected product; check all inventory locations within your institution; remove any identified product from your shelves and return to Bard Peripheral Vascular, Inc. 1415 W. 3rd Street, Tempe, AZ 85281; if you have further distributed any of the product, immediately contact that location and advise them of the recall and have them return to BPV; If you have used the affected product, consider notifying, educating and monitoring those affected; and complete and return the Recall and Effectiveness Check form via fax to: ATTN; Recall Coordinator in Customer Service at 1-800-994-6772, even if you no longer have possession of the product; if unable to FAX call BPV at 1-800-321-4254 Option #2 Ex 2727 and report verbally. Please call our Recall Coordinator at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at HUsilvia.carrillo@crbard.com with any questions.

Device

  • 모델명 / 제조번호(시리얼번호)
    PC 863017D; Lot: HUWL0010
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
  • 제품 설명
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 || The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • 제조사 모회사 (2017)
  • Source
    USFDA