Events

Retiro De Equipo (Recall) de Device Recall King Systems KLTD Oropharyngeal Airway

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 King Systems 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
    57970
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1706-2011
  • Fecha de inicio del evento
    2011-01-14
  • Fecha de publicación del evento
    2011-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97875
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Causa
    King systems has been notified by triad group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use of this product may result in "patient infection". because this particular sterile lubricating jelly is packaged in the king lt-d kit and king lts-d kit, king systems is sending a notice of the reca.
  • Acción
    The firm, King Systems, sent an "URGENT PRODUCT RECALL" letter dated January 14, 2011 to its customers. King Systems sent a follow-up "URGENT PRODUCT RECALL" letter dated March 3, 2011 which "SUPERSEDES" the January 14, 2011 recall letter with attached instructions to its customers. The letters described the product, problem and actions to be taken by the customers. The customers were instructed to notify all their purchasers of this recall; immediately cease sales and use of the affected products; identify all inventory on hand or returned to them by their customers; REMOVE Triad Group lubricant from King LT-D and LTS-D kits according to King instructions; quarantine the Triad lubricant, re-seal the LT-D and LTS-D kits and destroy Triad lubricant or return to Triad according to King instructions, and complete, sign and return Recall Acknowledgement Form via fax to: 317-776-6827 or email to: triadluberecall@kingsystems.com. King Systems will provide replacement lubricant packs to all customers. Customers with questions regarding product return, replacement, hospital notification or concerning the information requested above, please contact Customer Service at 1-800-642-5464. If you have any regulatory questions about the recall, please contact Director of Quality Assurance and Regulatory Affairs at 1-800-642-5464.

Device

Device Recall King Systems KLTD Oropharyngeal Airway
  • Modelo / Serial
    Product Code 10-0003, Lots: IK022, IKM04, IKM06, IKM05, IKM07, IKM03, IK021, IK019, IK020, IK018, IK017, IK016, IK015, IK013, IK014, IJZX9, IJZB4, IJZ48, IJUK7, IJU57, IJTV5, IJK96, IJJM1, IIS66, IIRY0, IIQB9, IIJU9, IIJU8, IIJU7, IHQ28, IHP29, IHNK0, II7K4, II8B3, II5M4, II557, II401, II1F5, IHEH2, IHEH1, IH7A8, IJPD1, IJPS4, IJJ81, ILJT7, ILJT8, ILJT9, ILJU0, ILRX1, ILRX2, ILRX3, ILRX4, IM5H3, IM5W3, IM872, IMST2, IMTI0, IMTW5, IMTU9, IMUB7, INEQ9, INER0, INER1, INER2, INER4, INER3, INU73, INU74, IP222, IP223, IPD19, IPD20, IPD21, IPWF7, IPZ81, IQ3Z1, IQ864, IQ865, IQBU4, IQC94, IQDP1, IQDP2, IQGZ4, IQHG8, IQTW0, IQTW1, IQTW2, IRI29, IRV93, IRV94, IRZR8, IS0D7, IS869, IS870, IS871, IS872, ISP35, ISP34, IT8F5, IT8F6, ITGP8, ITGP9, IU0M0, IU0M1, IU0Q7, IU0Q8, IU975, IU976, IU977, IU978, IU979, IUF29, IUFK9, IUM83, IUM84, IUM85, IUM86, IUSH1, IUS79, IUVA6, IUW24, IV063, IV064, IV065, IV066, IV5M1, IV5M2 and IV5M3.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including: CA,CO, FL, ID, IN, KS, NC, NH, NY, OH, PA, PR, SC, TN, and TX; and Country of: Canada.
  • Descripción del producto
    KING LTD, SIZE 4, QUANTITY 1 EACH, || Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, ¿15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, www.kingsystems.com || Size 4: Medium adult disposable oropharyngeal airway. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • Dirección del fabricante
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • Empresa matriz del fabricante (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA