Events

Rappel de Device Recall King Systems LTD Oropharyngeal Airway Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par King Systems Corp..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57970
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1714-2011
  • Date de mise en oeuvre de l'événement
    2011-01-14
  • Date de publication de l'événement
    2011-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97891
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Cause
    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.
  • Action
    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 LTD Oropharyngeal Airway Kit
  • Modèle / numéro de série
    Product Code KLTD212, Lots: IKMU8, IKH43, IK8W4, IK5A3, IK1P6, IKTW8, IKSE1, IKQN4, IKLB8, IKJI5, IKEU1, IK787, IKVH6, IKU55, IKY59, IKZP7, IL1U6, IL3I0, IL579, IL6N3, ILAF1, ILE81, ILF80, ILIE5, ILN70, ILKL1, ILK87, ILP53, ILTJ0, ILWF9, ILY47, IM124, IM1T4, IM411, IM7G2, IM951, IMEH3, IMB57, IMIJ6, IMLE4, IMMA7, IMNJ0, IMQW8, IMSQ7, IMU92, IMV74, IMWS5, IMY33, IMZG4, IN5A3, IN7Q9, IN8A8, IN9A9, INDC4, INHS0, INJ13, INQE4, INUU1, INY17, IP1F5, IP317, IP6E5, IPAL1, IPBP2, IPCY6, IPHE0, IPKX1, IPQC6, IPST1, IPWC5, IPXT4, IQ1D0, IQ3V0, IQ973, IQ9Q4, IQDJ6, IQEY4, IQKZ8, IQP19, IQSR5, IQW61, IR1F9, IR335, IR6I2, IR8Z1, IRFA8, IRGS8, IRMR6, IRMR7, IRX29, IS215, IS583, IS876, ISC25, ISEU8, ISIG1, ISJS6, ISRV1, ISSF9, ISTT8, ISW46, ISZ79, ISYD6, IT066, IT5E2, IT7Y4, ITB35, ITE17, ITIV2, ITLB5, ITQR7, ITTS6, ITXJ4, IU1W6, IU3Z0, IU7M3, IUAL7, IUCR0, IUE12, IUG37, IUIK6, IUKN1, IUP41, IUWZ5, IV144, IV3F3, IV698 and IV7T7.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including: CA,CO, FL, ID, IN, KS, NC, NH, NY, OH, PA, PR, SC, TN, and TX; and Country of: Canada.
  • Description du dispositif
    KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Made in the U.S.A. || 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.
  • Adresse du fabricant
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • Société-mère du fabricant (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA