Bard Access 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems 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
    70430
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1275-2015
  • 사례 시작날짜
    2014-08-08
  • 사례 출판 날짜
    2015-03-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-08-05
  • 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
    Catheter, percutaneous - Product Code DQY
  • 원인
    Some unit packages of bd posiflush sf saline flush syringe 10 ml may exhibit open seals, which could impact product sterility. bard includes these pouched syringes, attached to some configurations of picc kits, port access kits (pak), powerglide kits, midline kits, and convenience kits.
  • 조치
    The firm, BD Medical, sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated July 22, 2014 and a follow-up "URGENT: Voluntary Product Recall-BD PosiFlush SF Saline Flush Syringe 10mL with rework instructions for applicable Bard Kits" letter dated August 8, 2014 to its customers and distributors. The letters described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory and quarantine product subject to the recall; complete and return the Recall Response Card form via fax to BD at 1-201-847-6990 or email to Becky_Saggau@bd.com and return all affected products. Note: If you do not have any of the affected lots in your inventory, please complete the Recall Response Card form indicating you have (0) quantity and fax or email. The distributors were instructed to immediately examine your inventory and identify any product subject to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this notification. Complete the attached Recall Reply Form and FAX to Bard Access Systems, Inc. at 1-801-522-5674, or EMAIL to BASD.fieldaction@crbard.com. Even if you do not have any inventory of the affected syringe lots. Please direct any return requests and questions to our coordinator at 800-290-1689. If you have any questions or require assistance with the return of the recalled product and/or availability of replacement product, please contact BD Customer Service at 1-888-237-2762 option 3.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 13FB8860 Product codes: CK000069
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) || The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
  • Manufacturer

Manufacturer