Events

SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Thomas Medical Products 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
    60236
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0168-2012
  • 사례 시작날짜
    2011-10-07
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104847
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    Radiopaque (ro)/soft tip of the braided core component in the csg kits may detach from the braided core tube.
  • 조치
    The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 7, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately segregate all affected product in a manner that ensures it will not be used; return any product with reference to the return authorization (RA) number or contact customer service representative to facilitate return of product; if any affected product has been forwarded to another facility, contact that facility to arrange return, and complete and return the attached product reconciliation form. If you have any questions, you may contact the Customer Service number at 1-866-446-3003 Monday through Friday from 8:30am to 5:00pm EDT.

Device

SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068.  Lot Numbers: S24064, S24120; S24129; S24359; S24618; S24683; S24838; S24932; S25222; S25489; S25540; S25544; S25772; S25937; S25945; S26333; S26420; S26460; S36539; S36540; S26560; S36759; S36861; S26881; S26987; S27221; S27222; S27275; S27288; S27370; S27477; S27478; S27947; S27971; S27985; S28023; S28172; S28306; S28339; S28401; S28632X1; S28791; S29083; S29878; S30060X1; S30262X1; S30332X1; S30333X1; S30622X1; S30630; S30739; S30852X1; S30889X1; S30901X1; S30913; S30919X1; S30956X1; S30970; S30986X1; S30997X1; S31005X1; S31045; S31076; S31080X1; S31081; S31097; S31098; S31142X1; S31212X1; S31215X1; S31245; S31306; S31316; S31327X1; S31331X1; S31334; S31340; S31341; S31439; S31507; S31533X1; S31534X1; S31535X1; S31563; S31650; S31674; S31709; S31771X1; S31779X1; S31917X1; S31962;S32102; S32139; S32156; S32167; S32178X1; S32219; S32222; S32238; S32263; S32282; S32308; S32327; S32506X1; S32543X1; S32565X1; S32566X1; S32568X1; S32602; S32605X1; S32610; S32675; S32684; S32699X1; S32714; S32715; S32716; S32717; S32737; S32765; S32796; S32831; S32882; S32957; S32994; S33026; S33065; S33067; S33076; S33084; S33129; S33149X1; S33161X1; S33236; S33238; S33301; S33322; S33324; S33398; S33399; S33403; S33412; S33478; S33543; S33544; S33614; S33649; S33687; S33758; S33889; S33921; S33939; S34026; S34082; S34096; S34342; S34375; S34485; S34689; S34690; S36110X1; and S36118X1.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA only.
  • 제품 설명
    SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068 || This device is intended to be used for the introduction of various types of pacing or defibrillator leads and catheters.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • 제조사 주소
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA