Events

Device Recall Terumo Pall AL6X Arterial Blood Line Filter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    65981
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2261-2013
  • 사례 시작날짜
    2013-07-26
  • 사례 출판 날짜
    2013-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121140
  • 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
    Filter, blood, cardiopulmonary bypass, arterial line - Product Code DTM
  • 원인
    Medical device used in cardiovascular procedures is defective.
  • 조치
    Terumo Cardiovascuolar Services sent recall letters to Chief of Perfusion, Director of Operating Room Services, Director of Biomedical Services, and Risk Management departments on July 26, 2013. The notifications advised that filters are being recalled because some of the filters may exhibit a partial or full occlusion of an outlet or purge port. Terumo CVS advised users to stop using Terumo AL6X arterial filters from the affected lot numbers for replacement. A supply of replacement filters for customer's immediate use accompanied the notification. For users ordering the AL6X filters as part of a Cardiovascular Procedure Kit, Terumo CVS is providing a preliminary supply of replacement Terumo AL6X arterial filters in which users may follow the instructions to replace the filter or users may return the Cardiovascular Procedure Kit and Terumo CVS will replace the filter for them. Customers with questions were advised to contact Terumo CVS Customer Service at 800-521-2818. For questions regarding this recall call 800-521-2818.

Device

Device Recall Terumo Pall AL6X Arterial Blood Line Filter
  • 모델명 / 제조번호(시리얼번호)
    Recalled filters sold singly are identified with Part Number AL6X with the following lot codes:  MM19,  MN23,  NC15,  ND01,  ND08,  ND29,  NE11,  NE18,  NE25,  NF09,  NF31,  PA23,  PD05,  PE02,  PF14,  PF21,  PG04,  PG11,  PG18,  PG25,  PH09,  PH16,  PH30,  PK06,  PK13,  PL24,  PM01,  PM08,  PM22,  PM29,  PN12,  PN26,  PP17,  PP31,  QA07,  QA14,  QA21,  QC04,  QC25,  QD11,  QD18,  QD25,  QE08,  QE15,  QE22,  QE29,  QF06,  QF28, MM26,  NL12,  NM24,  NP12, and PA30;    Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes:  PN19,  QA14,  QC11R,  QD04,  QE15,  QF06,  QF13,  NM31,  NP05,  PC20,  PD05,  QF28,  QC04,  PD26,  PG04,  PE23R,  PK13,  PK20,  QA21,  QC11,  QC11A,  QD11,  QE01,  PL17,  QE08,  NK08,  PG25,  PN26,  QC18,  NN07,  NN07R,  PA16,  PA16R,  PC27,  PC27R,  PF07,  PL24,  PD12,  PE09,  PE30,  PH09,  PL10,  PE23,  PF14,  PG18,  PK06,  PM01,  PM22,  PN12,  QA02,  QA28,  QC25,  QD25,  NK01,  NK08R,  PH23,  PH16,  PL10A,  PM15,  PP10,  PP17,  QD18,  QE22,  NM17,  NM17A,  PC06,  PC06R,  PE09R,  QE01A,  QE15A,  QE15T,  QE15TA,  QE15TC,  QF13T,  QF20,  QF20T,  NA10R,  NA17R,  ND14,  ND28,  ND28T,  NE11T,  NE18,  NF23,  NG06,  NG20,  NH11,  NH18,  NK15,  NL12,  NL26,  NM03,  NM10,  NM24,  NN14,  NN28,  NP12,  PA30,  PC13,  PD19,  PE16,  PF07A,  PF21,  PK27,  PK27A,  PL04,  PM08,  PP03,  QA14T,  QE29,  QF28T,  QF28TA,  PG11,  PH30,  PH30A,  PN26A,  QA07,  NH25,  NK29,  PE02,  PF29,  PN19,  QG17,  PK13A,  QD11A,  MN22,  NE25,  NF31,  PM29,  PA09,  QG03,  PA02,  PH23T,  PG11T,  QC18R,  QF06A,  PH09T,  PH09TA,  QF13TA,  QF20TA, and QF20TC
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.
  • 제품 설명
    Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit || Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA