Events

Retiro De Equipo (Recall) de SpeediCath , SpeediCath with Accessories

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 Coloplast Manufacturing US, LLC.

¿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
    58681
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2410-2011
  • Fecha de inicio del evento
    2011-04-21
  • Fecha de publicación del evento
    2011-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99905
  • 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
    Catheter, urethral - Product Code GBM
  • Causa
    Coloplast has initiated a recall on speedicath with insertion supplies and surecath set with insertion supplies because they contain iodine prep pads which may expire before the overall product expiration date. speedicath with insertion supplies and surecath set with insertion supplies are both packaged with a set of accessories which includes iodine prep pads. the iodine prep pads included i.
  • Acción
    Coloplast Manufacturing US, LLC sent a Coloplast "Product Field Correction Notice" dated April 21, 2011. The letter was addressed to "Dear Valued Customer". The letter described the problem and the product involved in the recall. Customers were advised to provide the current inventory levels of the lots affected and the firm will be providing them with new iodine prep pads with sufficient shelf life. This product will include customer instructions, informing the customer to discard the original prep pads and use the new prep pads instead. If they prefer, they could themselves send the affected product back to Coloplast and they in return will attach new prep pads to the product for them. If they have further distributed the product, they advised consignees to contact their customers and to include the letter provided to them to inform them of the recall.

Device

SpeediCath , SpeediCath with Accessories
  • Modelo / Serial
    2641603 2692541 2752163 2771698 2803598 2395370 2440555 2509063 2516364 2524050 2651814 2668369 2712685 2717532 2727614 2740196 2752164 2771659 2785552 2803602 2018979 2337367 2365131 2365132 2365134 2365135 2564957 2600245 2641600 2668412 2679492 2692543 2712686 2717531 2727613 2752165 2761468 2771696 2803595 2283082 2465091 2651905 2679493 2692545 2712687 2752166 2757289 2771701 2785553 2803599 2130238 2345466 2403178 2651870 2771700 2651868 2771695 2803600  2233842 2233842 2283075 2583200 2600244 2668374 2679497 2752168 2771692 2785551 2803601 2556881 2668363 2679495 2727615 2752169 2771694 2785548 2803597 2082467 2327518 2403253 2641601 2692542 2727612 2752170 2771697 2803596 2442703 2648503 2679494 2761467 2785554 2474786 2668366 2752167 2771702 1930978 2411690 2509038 2651872 2679496 2717533 2761247 2771691 2785550
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.
  • Descripción del producto
    SpeediCath , SpeediCath with Accessories || Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark || 284821 1400 SpeediCath, acc CH10 Male || 284831 1400 SpeediCath, acc CH12 Male || 284841 1400 SpeediCath, acc CH14 Male || 284851 1400 SpeediCath, acc CH16 Male || 284861 1400 SpeediCath, acc CH18 Male || 284811 1400 SpeediCath, acc CH8 Male || 285011 1400 SpeediCath,acc CH10 Female || 285021 1400 SpeediCath,acc CH12 Female || 285031 1400 SpeediCath,acc CH14 Female || 285041 1400 SpeediCath,acc CH16 Female || 284991 1400 SpeediCath,acc CH6 Female || 285001 1400 SpeediCath,acc CH8 Female || The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urin to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Dirección del fabricante
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Empresa matriz del fabricante (2017)
    Coloplast A/S
  • Source
    USFDA