Device Recall King Systems LTD Oropharyngeal Airway Kit

  • Modèle / numéro de série
    Product Code KLTD2125, Lots: IK1P7, IK5A4, IK788, IK8W5, IKEU2, IKCX6, IKH44, IKJI6, IKLB9, IKMU9, IKQN5, IKSE2, IKTW9, IKU56, IKY60, IKVH7, IKZP8, IL3I1, IL374, IL580, ILE82, ILF81, ILG29, ILJI3, ILKL2, ILLF0, ILN71, ILP54, ILUK7, ILZQ6, IM3C2, IM645, IM952, IMBG5, IMD50, IMHV2, IMMA8, IMQW9, IMSQ8, IMUM2, IMV75, IMWS6, IMY34, IN4W0, IN605, IN7R0, INAR2, INCA3, INDC5, INFL0, INGI2, INJ14, INLF0, INRE8, INY18, INZE5, IP1F6, IP205, IP318, IP6E6, IP8M7, IPAL2, IPBP3, IPCY7, IPG50, IPHE1, IPMK8, IPPE2, IPWC6, IQ0P1, IQ1D1, IQ325, IQ3V1, IQ8V0, IQ974, IQDJ7, IQEY5, IQKZ9, IQP20, IQSR6, IQWZ1, IR1L6, IR336, IR7D6, IR9U5, IRGS9, IRM78, IRMR8, IRMR9, IRX30, IRZT5, IS877, ISC26, ISE37, ISIW8, ISJS7, ISRZ0, ISSG0, ISTT9, ISUW4, ISYD7, IT067, IT2U2, IT5E3, IT7Y5, ITAD8, ITE18, ITH84, ITIV3, ITPI6, ITQ80, ITTS7, ITVF7, ITZJ4, IU1W7, IU2L3, IU3Z1, IU6V6, IUAL8, IUHE3, IULD2, IUTA5, IUWZ6, IV145, IV3F4 and IV699.
  • Classification du dispositif
  • 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, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2.5, 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
  • 1 Event

Fabricant

  • Adresse du fabricant
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • Société-mère du fabricant (2017)
  • Source
    USFDA

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  • 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
  • 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
  • Modèle / numéro de série
    Product Code KLTD213, Lots: IHQW1, IIXA9, IICI6, II709, II534, II1B7, IHPK8, IIVT3, IISI8, IJJW1, IIPK4, IIKL9, IIJ74, II970, II374, IK0I5, IK0Y7, II533, IK3H8, IHYQ3, IHZ50, IK8W6, IHY03, IHV33, IHT05, IKB54, IHRD5, IKH45, IKLC0, IKQN6, IKSE3, IHMD9, IKU57, IHK62, IHHC5, IHGB2, IJHU6, IJLM5, IJQC5, IJTE1, IJVT8, IJFW1, IIAQ3, IJ4F2, IJX62, IK5A5, IKEU3, IJ6A8, IJ9V9, IJWD6, IK4W5, IKVH8, IKY61, IKZP9, IL1U7, IL6N4, ILDD4, ILQB7, ILTJ1, ILV48, ILWG0, ILZQ7, IM125, IM953, IMB58, IMEH4, IMGX7, IMIJ7, IMJZ0, IMNJ1, IMR97, IMS99, IMV76, IMY35, IN1Q7, IN397, IN9R3, INDC6, INHS1, INNM3, INQE5, INTG0, INY19, IP161, IP3N5, IP8M8, IPAL3, IPBP4, IPCY8, IPE37, IPGR8, IPIG5, IPKX2, IPMK9, IPPE3, IPWC7, IPXT5, IPYA9, IQ326, IQ653, IQ4Z2, IQ8V1, IQ975, IQBR4, IQC57, IQDJ8, IQEY6, IQKI3, IQP21, IQSR7, IQUR7, IR1L7, IR9U6, IR9U7, IREA0, IRM79, IRMS0, IRMS1, IRX31, IRXV1, IRZT6, IS216, IS878, ISC27, ISIW9, ISJS8, ISJS9, ISRV2, ISSG1, ISTP8, ISU98, ISW47, ISYD8, ISZ80, IT183, IT5E4, IT7Y6, ITDC2, ITAD9, ITE19, ITI16, ITJH1, ITPI7, ITQ81, ITRZ2, ITTS8, ITW61, IU2U6, IU3Z2, IU7M4, IUAL9, IUBN5, IUFH2, IUJF2, IUNM5, IUTA6, IUVX9 and IUY61.
  • Classification du dispositif
  • 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, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 3, 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
  • Modèle / numéro de série
    Product Code KLTD214, Lots: IHGB3, IHH94, IHLZ2, IHPZ2, IHRT5, IHTA4, IHWT5, IHZ51, II1B8, II536, II710, IIAQ4, II971, IICI7, IIJ75, IINU2, IIQJ4, IIVT4, IIWX7, IJ6A9, IJ9W0, IJE36, IJJW2, IISI9, IJLM6, IJNP8, IJQC6, IJTE2, IJWD7, IJVT9, IJX63, IJYS1, IJZ37, II2B9, IK3H9, IK4W6, IK789, IK8W7, IKEU4, IKH46, IKLC1, IKQN7, IKSE4, IIQJ3, II535, IHDV7, IKCX7, IKB55, IKU58, IKY62, IKVH9, IL1U8, IL6N5, IL8Y0, ILGE7, ILT63, ILV49, ILWG1, ILY48, IM126, IM1T5, IM954, IMAT2, IMBG6, IMGX8, IMIJ8, IMJJ6, IMNL7, IMR98, IMRI3, IMVN6, IMY92, IN1Q8, IN398, IN4W1, IN606, IN8U2, INCA4, INDW6, INFL1, INHS2, INIL3, INKH3, INLF1, INLT3, INMU3, INQE6, INS34, INW92, INY20, INZ16, IP4A9, IP4M6, IP6Y9, IP9B4, IPAL4, IPCY9, IPEQ9, IPIG6, IPJB3, IPKX3, IPN25, IPNS1, IPQC7, IPR19, IPST2, IPVK7, IPWC8, IPXT6, IPYB0, IQ263, IQ3V2, IQ4Z3, IQ8V2, IQ976, IQ9Q5, IQBR5, IQC58, IQDJ9, IQEY7, IQHC7, IQKI4, IQP22, IQUR8, IQZ79, IR1L8, IR9U8, IRAE9, IREA1, IRGT0, IRI32, IRM80, IRMS2, IRMS3, IRMS4, IRX32, IRXV2, IS217, IS218, IS584, IS879, ISC28, ISEU9, ISIX0, ISJT0, ISJT1, ISSG2, ISTP9, ISU99, ISUW5, ISWQ7, ISZ81, IT4K8, ITY7Y, IT7Y7, ITAE0, ITFH0, ITE20, ITFQ7, ITI17, ITMA1, ITPI8, ITSG9, ITW62, ITYX5, IU2U7, IU3Z3, IU7M5, IUAM0, IUC35, IUEI3, IUJF3, IULD3, IUS00, IUU61, IUY62 and IV147.
  • Classification du dispositif
  • 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, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 4, 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
  • Modèle / numéro de série
    Product Code KLTD215, Lots: IHDV8, IHGB4, IHH95, IHME0, IHPZ3, IHRD6, IHT06, IHWT6, IHYQ4, IHZ52, II375, II538, II711, II972, IIAQ5, IIEE4, IIJ76, IIQT3, IIQT4, IIVT5, IJ1U4, IJ6B0, IJAI6, IJQC7, IJRS4, IJTE3, IJWD8, IJX64, IK0I6, IK4W7, IK8W8, IKB56, IKCX8, IKEU5, IKH47, IKJI7, IKMV0, IKQN8, IKSE5, IKU59, IK5A6, IJ898, IIQT5, IISJ0, II537, II1B9, IK3I0, IIPK5, IIP58, IKVI0, IKY63, IL6N6, ILF82, ILP55, ILQS8, ILTJ2, ILWG2, ILY49, IM127, IM9E4, IMB59, IMD51, IMGX9, IMIJ9, IMPJ8, IMQX0, IMUM3, IMVN7, IMZG5, IMY93, IN7R1, IN8U3, INBT2, INDC7, INGI3, INHS3, INIL4, INKH4, INNA9, INNM4, INQE7, INTG1, INVM3, INY21, INZ17, IP206, IP8M9, IPAL5, IPCZ0, IPE38, IPGR9, IPHE2, IPIG7, IPKX4, IPPE4, IPT79, IPWC9, IPXT7, IQ264, IQ327, IQ3V3, IQ654, IQ977, IQ8V3, IQDK0, IQEY8, IQL00, IQP23, IQUR9, IR1L9, IR9U9, IR9V0, IREA2, IRGT1, IRM81, IRMS5, IRMS6, IRX22, IRX33, IRXV3, IRZT7, IS219, IS220, IS585, IS880, ISC29, ISEV0, ISIG2, ISJT2, ISSG4, ISSG3, ISTQ0, ISVP2, ISW48, ISYD9, ISZ82, IT2U3, IT5E5, IT7Y8, ITAE1, ITET6, ITI18, ITMA2, ITPI9, ITQR8, ITTS9, ITSH0, IU2U8, IU3Z4, IU6V7, IUAM1, IUBN6, IUCR1, IUFH3, IUHE4, IUKN2, IUQL2, IUUG0, IUUS5, IUY63, IV148.
  • Classification du dispositif
  • 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, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 5, 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
  • Modèle / numéro de série
    Product Code KLTSD414, IHB85, IHBW0, IHDW0, IHGB6, IHH97, IHJ96, IHLL4, IHLZ4, IHPZ5, IHRD8, IHT08, IHV36, IHUK2, IHW44, IHWW4, IHYQ6, IHZ54, II1U6, II1C2, II396, II540, II610, II975, II713, II9Y6, IICI9, IIEE6, IIJ78, IIPK7, IIRW3, IISJ2, IIVT7, IIZD1, IJ1U6, IJ3N2, IJ6B2, IJ9C0, IJAI7, IJCX8, IIY19, IJCX9, IJE38, IJFW3, IJHU8, IJJW4, IJLN0, IJLN1, IJLN2, IJNQ0, IJPQ9, IJQR1, IJRS6, IJSS3, IJT04, IJTE5, IJTT2, IJVG7, IIJI6, IJX65, IJYS3, IJZX3, IK0I8, IK1P9, IK3I2, IK4G3, II1C1, IK5A8, IK6U1, IK8X0, IK907, IKCY0, IKEU7, IH9S5, IKHJ4, IKMV3, IKNA4, IKPE2, IKQP0, IKSE7, IKU61, IIME2, IK9M9, IKD12, IKH49, IKU62, IKU63, IKY65, IKY66, IKZ56, IL3I2, IL1V0, IL6N8, ILDD6, ILE84, ILF84, ILIE7, ILK88, ILRZ9, ILS00, ILSC8, ILSC7, ILSC9, ILSD0, ILU72, ILWG6, ILWG7, ILWG8, ILWG9, ILWW7, IM956, IMGY0, IMJJ8, IMQX2, IMR99, IMRI4, IMWB9, IMWF6, IMXW9, IMY36, IN2Y9, IN4H4, IN5K6, IN7R2, INAR4, INDC8, INDW7, INDW8, INDW9, INKH5, INLF2, INQE9, INRF0, INTG3, INUE1, INUU2, INW93, INV48, INVM5, INY23, INZ19, INZE7, IP163, IP1F8, IP320, IP1L9, IP4B0, IP4M8, IP6E8, IP6Z1, IP8A5, IP9B6, IPBP6, IPCA7, IPE39, IPG52, IPHE4, IPJB4, IPJY8, IPKX6, IPM52, IPNS3, IPN27, IPPE6, IPQC9, IPR21, IPR22, IPST4, IPT81, IPTE5, IPVK9, IPXB7, IPWD1, IPXT8, IQ1D3, IQ2K0, IQ329, IQ428, IQ3V5, IQ656, IQ4Z4, IQ7W1, IQ8V4, IQBR6, IQC60, IQC61, IQDK1, IQEZ0, IQHC8, IQKI6, IQIS2, IQMT5, IQQD1, IQP25, IQRT4, IQSR9, IQTT5, IQXU0, IQY12, IR1M1, IQZ80, IR337, IR9V5, IR9V4, IR9V6, IR9V7, IR9V8, IRAF0, IRFA9, IRCG1, IRGT2, IRM83, IRMR5, IRMT0, IRM84, IRMT1, IRV95, IRX23, IRX26, IRX24, IRX25, IRZT8, IRZT9, IRZU0, IS221, IS586, IS882, IS883, ISC32, ISC33, ISC34, ISEV2, ISIG4, ISIX2, ISJT4, ISJT5, ISPS3, ISNY7, ISRZ1, ISR41, ISSG5, ISTQ2, ISUA1, ISW50, ISR40, ISWQ8, ISWY3, ISXP8, ISZ84, IT069, IT2U5, IT4K9, IT5E7, IT7K4, IT7Y9, ITAE2, ITB36, ITET8, ITGI5, ITI19, ITKA2, ITMA4, ITNT2, ITQ82, ITQR9, ITRF6, ITS82, ITTT1, ITVF8, ITXJ5, ITYX7, IU1J1, IU3Z6, IU662, IUBN8, IUCR3, IUFH5, IUI13, IUN51, IUKN3, IUSP4, IUR91, IUU63, IUVY1, IUY65, IUYR7, IV021, IV020, IV0L3, IV2H7, IV5R9 and IV715.
  • Classification du dispositif
  • 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, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 4, 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
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