Baxter INTERLINK System, NonDEHP Catheter Extension Set Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    56792
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0355-2011
  • 사례 시작날짜
    2010-09-17
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-10-04
  • 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
    Device, vein stabilization - Product Code LBJ
  • 원인
    The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. the device is labeled as nonpyrogenic.
  • 조치
    Baxter issued Urgent Product Recall letters dated September 17, 2010 to the affected direct accounts. The accounts were informed that the paper lining covering the adhesive strip that is used to secure the catheter stabilization device to the patient was found to be pyrogenic. The accounts were requested to discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Clinical questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303. Any other questions may be directed to the Center for One Baxter at 1-800-422-9837.

Device

  • 모델명 / 제조번호(시리얼번호)
    catalog 2N8221, lot numbers R10A25110
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: Throughout the US.
  • 제품 설명
    Baxter INTERLINK System, Non-DEHP Catheter Extension Set Kit; 7.1" (18.0 cm), Vol. 0.85 mL, 1 Catheter Extension Set with injection site and male luer lock adapter with retractable collar, 1 VITAL-HOLD Medium Catheter Stabilization Device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8221
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA