Events

Retiro De Equipo (Recall) de Device Recall Centurion

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 Centurion Medical Products Corporation.

¿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
    68989
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2670-2014
  • Fecha de inicio del evento
    2014-07-25
  • Fecha de publicación del evento
    2014-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129215
  • 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
    Saline, vascular access flush - Product Code NGT
  • Causa
    Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
  • Acción
    Centurion sent an Urgent Product Recall Notice dated July 25, 2014, to all affected customers via Certified Mail. The notification discussed the affected product issue and provided instructions for initiating product return. Customers were instructed to identify and remove all inventory of these kits that they may have within their possession. Customers were asked to forward a copy of the notice to any customers to whom this product may have been further distributed. Customers were also asked to complete the enclosed accountability record, whether or not they have the product, and fax or email at their earliest convenience to 517-546-3356 or lcarpenter@centurionmp.com. Customers with questions were instructed to call (517) 546-5400, Ext 1135. For questions regarding this recall call 517-546-5400, ext 1156.

Device

Device Recall Centurion
  • Modelo / Serial
    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits: Kit Code/Description: CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers: 2013082850, 2013092650; Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180;  Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350,2013082950, 2013091250;  Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880; Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950; Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780;  Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150; Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380;  Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980; Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880,  2013111180;  Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750;  Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480; Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080;  Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280;  Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780; Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180; Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880; Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080;  Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080; Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180;  Kit Code/Description: DT17300/NEONATAL CAP CHANGE KIT, Lot Numbers: 2013052880, 2013111880; Kit Code/Description: DT17410/ON/OFF KIT & DRESSING CHANGE TRAY, Lot Numbers: 2013050680, 2013061780; Kit Code/Description: DT17880C/DRIVELINE MGMT SYST - PROTOCOL 2, Lot Number: 2013040180;  Kit Code/Description: ECVC150/MULTI-LUMEN CVC KIT W/ELS VANTEX CATHETE, Lot Number: 2013091950;  Kit Code/Description: ECVC355/ CHARLES COLE CVC INSERTION BUNDLE, Lot Numbers: 2013082050, 2013091950; Kit Code/Description: ECVC510/CENTRAL LINE INSERTION TRAY, Lot Number: 2013081550; Kit Code/Description: ECVC585/CENTRAL LINE INSERTION TRAY BUNDLE, Lot Number: 2013082950; Kit Code/Description: ECVC705/7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Lot Number: 2013091750;  Kit Code/Description: ECVC740/MULTI-LUMEN CVC BUNDLE, Lot Number: 2013092650; Kit Code/Description: HT5525/V.A.D.KIT, Lot Number: 2013062480; Kit Code/Description: HT5545/SUB-PORT ACCESS TRAY: Lot Number: 2013052880; & Kit Code/Description: IV7610/ARTERIAL LINE INSERTION KIT, Lot Numbers: 2013052080.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.
  • Descripción del producto
    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Dirección del fabricante
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA