Events

Device Recall Baxter Combined Epidural Anesthesia Trays 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
    34381
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0508-06
  • 사례 시작날짜
    2006-01-10
  • 사례 출판 날짜
    2006-02-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43873
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • 원인
    The bd catheter connector contained in the epidural anesthesia trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
  • 조치
    Baxter sent Urgent Product Recall letters dated 1/10/06 to their customers, to the attention of the Director of Anesthesia, via first class mail on the same date. The accounts were informed that the BD catheter connector in the tray may not fully secure the catheter, resulting in the possible leakage or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and destroy it for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Combined Epidural Anesthesia Trays
  • 모델명 / 제조번호(시리얼번호)
    product code 1T5771, lot GD822783;  product code 2T2076, lot GD822932;  product code 2T2097, lot GD822940;  product code 2T2201, lot GD822817;  product code 2T2215, lot GD822825;
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Baxter Combined Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing a spinal needle, an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the spinal needle or epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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