Events

Retiro De Equipo (Recall) de SureCath Set 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-2409-2011
  • 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=99904
  • 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, straight - Product Code EZD
  • 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

SureCath Set with Accessories
  • Modelo / Serial
    2254413 2274655 2292666 2320403 2338378 2374932 2392592 2399378 2410209 2449677 2577563 2622543 2679855 2715298 2800737 1948430 1958550 1989592 2012653 2034816 2092501 2131525 2138388 2164741 2182404 2191497 2219280 2274657 2312433 2368610 2374934 2384654 2399380 2410211 2419491 2425315 2438175 2443207 2493708 2548751 2587259 2645801 1958552 1973438 1989594 2034818 2131527 2149340 2157258 2164743 2171582 2191499 2198648 Lot # 2501477 2511407 2516997 2541835 2548759 2558098 2587275 2594523 2622557 2631551 2645821 2679873 2721882 2731971 2747698 2763519 2778778 1958566 1965502 1989608 2034830 2092519 2123378 2164757 2171590 2182418 2198660 2207861 2219296 2236677 2254425 2265768 2274679 2302517 2312445 2330870 2338396 2348637 2368628 2374962 2384668 2392610 2399400 2410233 2493726 2523184 2558094 2594521 2622555 2645819 2771300   Lot # 2312449 2320417 2338400 2348641 2368634 2374968 2384674 2392616 2449691 2456477 2485594 2501481 2541841 2548763 2558106 2566842 2602042 2622559 2631555 2645825 2721886 2731975 2747702 2771304 2778782 2794747 1948450 1958568 1965506 1989612 1997366 2052390 2060461 2117596 2131535 2149356 2164761 2171594 2198664 2207865 2219300 2236679 2265774 2274683 2302519 2312447 2320415 2330872 2348639 2357947 2368632 2374966 2384672 Lot # 2117600 2138412 2219304 2236683 2493728 2577571 2721888 2731977 2747704 2778784 2794749  2207849 2219282 2227510 2236663 2254415 2265758 2274659 2302511 2320405 2330856 2338380 2348623 2368612 2374936 2384656 2392594 2399382 2410213 2419493 2449679 2485578 2493710 2541827 2587261 2602024 2645803 2679857 2747684 2778768 1965504 1989610 1997364 2012665 2077906 2101463 2117594 2123380 2138408 2164759 2171592 2191515 2198662 2207863 2219298 2254427 2265770 2274681 2384670 2399402 2410235 2419511 2473122 2485590 Lot # 1948448 1973450 2052388 2191517 2227518 2263689 2265772 2338398 2368630 2374964 2392612 2410237 2425333 2541837 2566838 2679875 2715306 2771302 2794743 2173017 1948481 1982599 1989998 1997371 2012670 2025933 2034832 2042902 2052392 2060463 2070470 2077908 2085687 2101465 2109176 2117598 2123382 2131537 2138410 2149358 2157270 2164763 2171596 2191519 2207867 2219302 2227520 2236681 2265776 2274685 2285188 2292678 2302521 Lot # 2392614 2399404 2410239 2425335 2438183 2449689 2456475 2476332 2485592 2501479 2516999 2523186 2541839 2548761 2558102 2566840 2577569 2587277 2594525 2602040 2631553 2638102 2645823 2664375 2709475 2721884 2731973 2740298 2778780 2788415 2794745 2800745 1989614 1997368 2025935 2060465 2092521 2131539 2138414 2149360 2191521 2312451 2338402 2348643 2368636 2374970 2384676 2399406 2402696 2410241 2419513 1948452 2101467
  • 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
    SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. || 28022S 1400 SureCath Set,acc CH8 Male,bulk || 28023S 1400 Surecath Set,acc CH10 Male,bul || 28024S 1400 Surecath Set,acc CH12 Male,bul || 280320 1400 SureCath Set,acc CH14 Male || 28032S 1400 Surecath Set,acc CH14 Male,bul || 28036S 1400 Surecath Set,acc CH14/1,2 Male || 28037S 1400 Surecath Set,acc CH16 Male || 280370 1400 Surecath Set,acc CH16 Male || 28033S 1400 Surecath Set,acc CH16 Male || 280360 1400 Surecath Set,acc CH14/1,2 Male || 280340 1400 SURECATH SET W.ACC FEM14` || The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. 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