510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1720-2011

KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 4, Manufacturer...

King Systems Corporation. / initiated 2011-01-14 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

King Systems Corp. began a recall of KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 4, Manufacturer: King Systems Corporation, 15011 Herriman... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1720-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
King Systems Corporation.
Product
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.
Product code
CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall
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
Root cause tag
manufacturing process
FDA root cause
Process control
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: [email protected]. 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.
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.
Product codes and lots
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.