Events

Rappel de Device Recall Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port

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
    54193
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0661-2010
  • Date de mise en oeuvre de l'événement
    2009-12-17
  • Date de publication de l'événement
    2010-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87803
  • 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
    vascular introducer - Product Code DYB
  • Cause
    Radiopaque sheath tip may fracture.
  • Action
    GE Healthcare Thomas Medical Products firm issued an Urgent Medical Device Correction email on 12/23/09 to the distributor to discontinue distribution and return any affected products. The distributor was instructed to conduct a sub recall regarding the issue. Press issued 1/29/2010.

Device

Device Recall Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with ...
  • Modèle / numéro de série
    Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09. Lot numbers: S16716, S17215, S17216, S17248, S17349, S17447, S17448, S17449, S17478, S17596, S17640, S17675, S17789, S17790, S17795, S17864, S18000, S18004, S18290, S18291, S18336, S18337, S18352, S18529, S18535, S18593, S18670, S18725, S18736, S18744, S18745, S18861, S18862, S18952, S18962, S18974, S19051, S19060, S19135, S19153, S19161, S19173, S19174, S19175, S19196, S19262, S19264, S19290, S19291, S19292, S19409, S19428, S19450, S19564, S19742, S19743, S19756, S19757, S19906, S19959, S19961, S19966, S19991, S20007, S20019, S20101, S20154, S20170, S20297, S20298, S20331, S20491, S20494, S20505, S20704, S20713, S20848, S21002, S21071, S21115, S21128, S21236, S21557, S21650, S21651, S21652, S21695, S22085, S22160, S22216, S22228, S22229, S22244, S22282, S22302, S22367, S22368, S22371, S22396, S22397, S22491, S22675, S22676, S22746, S23020, S23021, S23022, S23052, S23092, S23103, S23111, S23112, S23225, S23384, S23387, S23388, S23402, S23403, S23492, S23507, S23508, S23543, S23618, S23795, S23926, S23927, S23956, S24026, S24027, S24101, S24174, S24175, S24341, S24353, S24354, S24355, S24619, S24620, S24772, S24800, S24852, S24906, S24907, S24931, S24951, S24956, S24958, S24978, S25050, S25051, S25052, S25082, S25097, S25121, S25140, S25141, S25142, S25239, S25241, S25323, S25324, S25353, S25404, S25433, S25469, S25486, S25487, S25494, S25497, S25590, S25590X1, S25594, S25720, S25721, S25806, S25807, S25896, S26039, S26039X1, S26040, S26040X1, S26088, S26095, S26183, S26183X1, S26345, S26554X1, S26570X1, S26576, S26635X1, S26636X1, S26637X1, S26752, S26754, S26833, S26834, S26912, S27030, S23031, S27032, S27056, S27057, S27186, S27242, S27321, S27504, S27610, S27611, S27617, S27646, S27670, S27876, S27895, S27913, S27914, S27924, S27952, S28054, S28214, S28215, S28232, S28272, S28273, S28283, S28326, S28360, S28391, S28460, S28485, S28564, S28576, S28731, S28808, S28894, S28939, S29270, S29492, S29669, S29736, S29766, S29767, S29813, S29823, S29879, S30059, S20357, S30060, S30258, S99009X1, S99010X1, S99011X1, and S99052X1.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.
  • 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