Events

Device Recall Huber Infusion Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Exelint International Co. 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
    54203
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0640-2010
  • 사례 시작날짜
    2009-12-23
  • 사례 출판 날짜
    2010-01-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87830
  • 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
    Hypodermic single lumen needle - Product Code FPA
  • 원인
    Coring of port's septum, which may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port.
  • 조치
    Distributors have been advised to cease distribution of any recalled needles and infusion sets; to quarantine any remaining; to document amount on Customer Response Form; to return form to Exel (firm); to arrange for return of product to Exel for credit. Distributors also are advised to share recall notice with all affected customers. Contact phone: 727-827-1922x0 (M-F 9a-5p EST). Contact email: info@exelint.com

Device

Device Recall Huber Infusion Set
  • 모델명 / 제조번호(시리얼번호)
    Catalog 27959R Lots: 07F25 08B04 08C29 08E23 08K26 09A10;  Catalog 27959R Lots: 07A19 07D25 09G21;  Catalog 27955R Lots: 07F18 07H23 07K26 08G14 08D10 08E22 08H05 08H23 09G21;  Catalog 27954R Lots: 08E09 08E21 08J22 09B23 09C28;  Catalog 27949R Lots: 07C20 07F26 07H03 07I 20 07I21 07K22 08B26 08E12 08G17 08K25 08L19 09D03 09F16 09G22 09H12;  Catalog 27948R Lots: 07I13 07J09 08G08 08I09;  Catalog 27950R Lots: 08D23 08E01 09D01;  Catalog 27945R Lots: 07A09 07A25 07F19 07G10 07J23 07K13 07L03 08A26 08B01 08B25 08E02 08F16 08H05 08J06 08J21 08K28 08L10 08L17 08L25 09A17 09C23 09C24 09D01 09D29 09E29 09F09 09F17 09G23;  Catalog 27944R Lots: 07A08 07B10 07B13 07B24 07F08 07F15 07G17 07H03 07H10 07J09 07L17 08A11 08C12 08C28 08D08 08F04 08H21 08I22 08K06 08K14 09A17 09A29 09B11 09B17 09D17 09G17;  Catalog 27946R Lots: 07A18 07C30 08D11 09D29 09F16 09G24 09H17;  Catalog 27941R Lots: 07I12 09B12 09C09 09F17 09H17;  Catalog 27940R Lots: 07I11 07L17 08I12 09D17.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (VA TX NV KY OH NH MS NY OH NM DE WA AZ IL PA OR CO FL GA LA UT MI WI NV CA NJ MO IA) and Canada.
  • 제품 설명
    Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, 27954R, 27955R, 27958R, 27959R).
  • Manufacturer
    Exelint International Co.

Manufacturer

Exelint International Co.
  • 제조사 주소
    Exelint International Co., P. O. Box 3194, Culver City CA 90231-3194
  • 제조사 모회사 (2017)
    Exelint International Co.
  • Source
    USFDA