Events

Retiro De Equipo (Recall) de FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes MultiPack.

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 Rochester Medical Corp.

¿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
    55765
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1907-2010
  • Fecha de inicio del evento
    2010-04-27
  • Fecha de publicación del evento
    2010-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92027
  • 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
    Transurethral occlusion insert, urinal incontinence-control, female. - Product Code OCK
  • Causa
    Rochester medical is voluntarily recalling specific lots of femsoft urethral inserts manufactured and distributed in 2009 and 2010. testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. if product sterility has been compromised, there is a potential for increased risk of urinary trac.
  • Acción
    Consignees were contacted by telephone on 5/3/10 and if not reached, were sent a Rochester Medical "Urgent Medical Device Recall" letter on 5/6/10 dated April 26, 2010. The letter was addressed to Rochester Medical Corporation Customers. The letter described the problem and product involved; recommended consignees to record the quantity and lot numbers (s) on the enclosed postcard and return it to them; and to immediately destroy the product with the lots affected. In the case of distributors, the telephone call was followed by a letter sent/dated April 27, 2010 to each distributor. It advised distributors to isolate any remaining inventory with the specified lot numbers and to complete the disposition report. Letters included a customer letter for dissemination to their retail level customers. Retail customers were asked to segregate and destroy the affected products and record the action. The company will replace the destroyed product. The distributors started their contact to consignees on 4/28/10. Please contact Rochester Medical at 1-800-243-3315, or the firm's Customer Service Department at 1-507-533-9309 for additional information or for product return & replacement instructions.

Device

FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes MultiPack.
  • Modelo / Serial
    REF Lot Pouch 70200 53500526 / 53500500  53500515  53500516  53500517  53500518  53500519  70200 53500591/ 53500598  53500601  53500604  53500586  53500587  53500588
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    AL, AK, AZ, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WY, WI,. AUSTRIA, BANGLADESH, CANADA, CYPRUS, ETHIOPIA, FRANCE, GERMANY, GREECE, INDIA, JAPAN, KOREA, NETHERLANDS, P.R. CHINA, SAUDI ARABIA, SCOTLAND, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM.
  • Descripción del producto
    FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. || Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. || The Multi-pack products contains 28 devices of the following: || -8 of size 1 Standard; || -4 of size 2 Standard; || -4 of size 3 Standard; || -4 of size 1 Long; || -4 of size 2 Long; and || -4 of size 3 Long.
  • Manufacturer
    Rochester Medical Corp

Manufacturer

Rochester Medical Corp
  • Dirección del fabricante
    Rochester Medical Corp, 1 Rochester Medical Dr Nw, Stewartville MN 55976-1647
  • Source
    USFDA