Events

Retiro De Equipo (Recall) de Device Recall 1) Thoracentesis Tray; 2) SafeT Thoracentesis Tray

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Carefusion 2200 Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66123
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2193-2013
  • Fecha de inicio del evento
    2013-08-28
  • Fecha de publicación del evento
    2013-09-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121524
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Needle, catheter - Product Code GCB
  • Causa
    Catheters included in thoracentesis tray and safe-t thoracentesis tray - drug free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
  • Acción
    Recall notification letters dated 8/27/13 were distributed via courier to direct accounts. Consignees were/are requested to confirm receipt of the notification, examine their inventory for the recalled products and to destroy the products. After the products are destroyed, the consignees are requested to submit a completed response form to CareFusion for replacement with functional devices. Consignees who cannot destroy the affected products are requested to contact CareFusion for additional information.

Device

Device Recall 1) Thoracentesis Tray; 2) SafeT Thoracentesis Tray
  • Modelo / Serial
    *** 1) Product Code: 4341B;  Lots: 554361 (Expires 11/30/15); 550463 (Expires 11/30/15); 548675 (Expires 11/30/15); 545891 (Expires 10/31/15); 544746 (Expires 10/31/15); 543978 (Expires 10/31/15); 542297 (Expires 10/31/15); 541063 (Expires 10/31/15); 539859 (Expires 10/31/15); 539470 (Expires 10/31/15); 537723 (Expires 9/30/15); 536497 (Expires 9/30/15); 535600 (Expires 9/30/15); 534616 (Expires 9/30/15); 532917 (Expires 8/31/15); 531869 (Expires 8/31/15); 530729 (Expires 8/31/15); 528789 (Expires 8/31/15); 526724 (Expires 8/31/15); 525767 (Expires 8/31/15); 523275 (Expires 8/31/15); 522256 (Expires 8/31/15); 517247 (Expires 7/31/15); 514103 (Expires 7/31/15); 512953 (Expires 7/31/15); 509413 (Expires 5/31/15); 508928 (Expires 5/31/15); 505191 (Expires 5/31/15); 504328 (Expires 4/30/15); 499957 (Expires 4/30/15); 498168 (Expires 4/30/15); 495057 (Expires 3/31/15), 492933 (Expires 3/31/15); 487660 (Expires 2/28/15); 486920 (Expires 2/28/15); 483377 (Expires 11/30/14); 481000 (Expires 11/30/14); 478361 (Expires 11/30/14); 476883 (Expires 11/30/14); 474403 (Expires 10/31/14); 471330 (Expires 10/31/14); 469597 (Expires 10/31/14); 469561 (Expires 10/31/14); 467093 (Expires 10/31/14); 464366 (Expires 10/31/14); 463156 (Expires 8/31/14); 461311 (Expires 8/31/14); 458579 (Expires 8/31/14); 456606 (Expires 8/31/14); 453734 (Expires 8/31/14); 450541 (Expires 8/31/14); 450540 (Expires 8/31/14); 446817 (Expires 8/31/14); 444048 (Expires 8/31/14); 440805 (Expires 8/31/14); 439236 (Expires 8/31/14); 436820 (Expires 8/31/14) ;433808 (Expires 7/31/14); 429003 (Expires 7/31/14); 427075 (Expires 7/31/14); 424115 (Expires 7/31/14); 420673 (Expires 6/30/14); 419197 (Expires 6/30/14); 417436 (Expires 6/30/14); 413285 (Expires 6/30/14); 411301 (Expires 6/30/14); 408552 (Expires 7/31/14); 405227 (Expires 6/30/14); 403653 (Expires 6/30/14); 400855 (Expires 6/30/14); 399197 (Expires 6/30/14); 389066 (Expires 5/31/14); 387167 (Expires 5/31/14); 382554 (Expires 5/31/14); 380046 (Expires 4/30/14); 377477 (Expires 4/30/14); 375047 (Expires 4/30/14); 372900 (Expires 4/30/04); 370763 (Expires 4/30/14); 370204 (Expires 3/31/14); 368133 (Expires 3/31/14); 366017 (Expires 3/31/14); 363544 (Expires 3/31/14); 362824 (Expires 3/31/14); 362000 (Expires 2/28/14); 359063 (Expires 2/28/14); 357349 (Expires 2/28/14); 352522 (Expires 1/31/14); 350387 (Expires 1/31/14); 348043 (Expires 1/31/14); 347360 (Expires 1/31/14); 343651 (Expires 10/31/14); 341316 (Expires 1/31/14); 339958 (Expires 1/31/14); 335395 (Expires 12/31/13); 333550 (Expires 12/31/13); 330580 (Expires 11/30/13); 327592 (Expires 11/30/13); 326052 (Expires 10/31/13); 322688 (Expires 10/31/13); 320605 (Expires 10/31/13); 316289 (Expires 9/30/13); 313891 (Expires 9/30/13); 312365 (Expires 9/30/13); 308400 (Expires 9/30/13); L1B129 (Expires 8/31/13); L1B177 (Expires 8/31/13); L1B215 (Expires 10/31/13); L1B311 (Expires 10/31/13); L1C150 (Expires 12/31/13); L1C190 (Expires 12/31/13; L1C273 (Expires 8/31/13); L1C376 (Expires 8/31/13);  *** 2) Product Code: 4341BSDF;  Lots: 548682 (Expires 2/28/18); 542824 (Expires 2/28/18); 528896 (Expires 12/31/17); 523596 (Expires 12/31/17); 522262 (Expires 12/31/17); 511661 (Expires 10/31/17); 486156 (Expires 8/31/17); 485085 (Expires 8/31/17); 469770 (Expires 6/30/17); 456730 (Expires 5/31/17); 437220 (Expires 3/31/17); 435599 (Expires 3/31/17); 363941 (Expires 8/31/16) 362922 (Expires 8/31/16); 354615 (Expires 7/31/16); 349218 (Expires 7/31/16); 347700 (Expires 7/31/16); 347346 (Expires 6/30/16); L1B185 (Expires 2/28/16); L1B321 (Expires 3/31/16); L1C201 (Expires 3/31/16); L0A238 (Expires 1/13/15); L0C212 (Expires 3/31/15); L0D150 (Expires 4/30/15); L0E143 (Expires 5/31/13); L0J242 (Expires 7/31/15); L0J274 (Expires 8/31/15); L0K270 (Expires 9/30/15); L0L264 (Expires 10/31/15); L0P117 (Expires 11/30/15); L0P126 (Expires 11/30/15); L9A294 (Expires 1/31/14); L9C267 (Expires 3/31/14); L9D320 (Expires 4/30/14); L9E238 (Expires 5/31/14); L9H237 (Expires 6/30/14); L9J212 (Expires 7/31/14); L9K261 (Expires 9/30/14); L9P191 (Expires 12/31/14); L8K258 (Expires 8/31/13); L8L229 (Expires 9/30/13); L8S323 (Expires 12/31/13)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MD, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and Puerto Rico, and the country of Iceland.
  • Descripción del producto
    *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; || *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. || Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Dirección del fabricante
    Carefusion 2200 Inc, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA