Events

Retiro De Equipo (Recall) de Device Recall Presource Custom Sterile Surgical and Procedure Kits

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 Cardinal Health.

¿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
    60845
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0925-2012
  • Fecha de inicio del evento
    2011-12-23
  • Fecha de publicación del evento
    2012-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106635
  • 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
    General surgery tray (kit) - Product Code LRO
  • Causa
    The presource kits were assembled with a jobri infant restraint strap which does not have the appropriate 510(k) pre-market clearance.
  • Acción
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 23, 2011 to the affected hospital consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected component upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit/replacement the consignees were instructed to contact the folowing: Hospitals - Presource Sales Operations at 800-766-0706; Federal Government facilities - Government Customer Service at 800-444-1166; and Distributors - Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.

Device

Device Recall Presource Custom Sterile Surgical and Procedure Kits
  • Modelo / Serial
    all recent lots of the following kit catalog numbers SBA48UMCHF, SMA21CIDCB, SMA21CRDCC, SMA21CRDCD, SRHHFCIMM1, SRHHFCIMM2, SRHHFCIMMA and SRHHFCIMMB
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Virginia, Washington and West Virginia.
  • Descripción del producto
    Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; || The kit catalog numbers listed in the code information section below contain one or more of the following listed components: || a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; || b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; || The restraint is used to secure an infant during a circumcision procedure. || Product Usage: || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Dirección del fabricante
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA