Device Recall Perifix FX Epidural Anesthesia Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 B. Braun 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
    78878
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0571-2018
  • 사례 시작날짜
    2017-06-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-04-03
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • 원인
    B. braun medical inc. (bbmi) initiated this recall of various bbmi convenience kits containing the 22ga 1-1/2in safetyglide needle due to the presence of loose polypropylene foreign matter was above release specification. this foreign matter has been identified as a product hub material which has been tested for biocompatibility per iso 10993 during the product development process.
  • 조치
    The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.

Device

  • 모델명 / 제조번호(시리얼번호)
    0061482582. 0061509281. 0061523764. 0061539142. 0061541519. 0061545624. 0061549251. 0061523766. 0061536442. 0061549079. 0061525251. 0061536434. 0061534703. 0061480989. 0061486228. 0061519902. 0061523684. 0061530885. 0061536042. 0061539966. 0061546081. 0061550336.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. || Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
  • Manufacturer

Manufacturer