Events

Rappel de SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Thomas Medical Products Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60236
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0168-2012
  • Date de mise en oeuvre de l'événement
    2011-10-07
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104847
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Introducer, catheter - Product Code DYB
  • Cause
    Radiopaque (ro)/soft tip of the braided core component in the csg kits may detach from the braided core tube.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: CA only.
  • Description du dispositif
    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
  • Adresse du fabricant
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA