—#98163

Product

KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, 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.

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
510(k) numbers: K021634, K033186
Affected lot / code info: Product Code KLTSD415, Lots: IH9S6, IHB86, IHBW1, IHDW1, IHGB7, IHH98, IHLZ5, IHPZ6, IHRD9, IHT09, IHV37, IHWG6, IHYQ7, IHZ55, II1C3, II397, II541, II611, II714, II976, II9K5, IIAQ7, IICJ0, IIEE7, IIJ79, IIJI7, IIKM0, IIPK8, IISJ3, IIVT8, IIWB5, IIWB4, IIXB0, IJ3N3, IJ6B3, IJ899, IJ9W2, IJBZ5, IJLN3, IJNQ1, IJPR0, IJQC9, IJQR2, IJRS7, IJT05, IJTE6, IJYS4, IJ131, IIZ43, IK0Y8, IK1Q0, IK3I3, IK5A9, IK6U2, IK8X1, IK9N0, IHUK3, IKCY1, IKEU8, IJX66, IKEU9, IKH50, IKKU9, IKLC3, IJVU1, IKNA5, IKMV4, IKQP1, IKU64, IKUV0, IJE39, IJCY0, IJJW5, IJHU9, IJHD7, IK0I9, IK908, IKB58, IKVI2, IL1V1, IKY67, IL3I3, ILD92, ILDD7, ILEK9, ILF85, ILFU3, ILIE8, ILK89, ILLF2, ILS01, ILS02, ILSD1, ILSD2, ILSD3, ILU73, ILVS3, ILWH0, ILWH1, ILYP5, IM3C3, IMHV3, IMIK0, IMLE5, IMPY0, IMRA0, IMSA0, IMWC0, IMWS8, IMYV2, IN1G9, IN4W3, IN7R3, IN9R4, INAA4, INAR5, INCA6, INDC9, INHS5, INIL5, INKH6, INNB1, INQF0, INR25, INTG4, INUE2, INUU3, INVM6, INV49, INY24, INZE8, INZ20, IP164, IP1F9, IP1M0, IP321, IP3N7, IP4B1, IP4M9, IP6E9, IP6Z2, IP8N0, IPAL7, IPBP7, IPCZ2, IPER0, IPG53, IPHE5, IPJB5, IPKX7, IPN28, IPNS4, IPPE7, IPQD0, IPR23, IPST5, IPT82, IPTE6, IPVL0, IPWD2, IPXT9, IQ1D4, IQ2K1, IQ330, IQ657, IQ4Z5, IQ7W2, IQ8V5, IQBR7, IQC62, IQDK2, IQEZ1, IQGX4, IQJU9, IQI21, IQP26, IQRT5, IQSS0, IQUS0, IQXU1, IR1M2, IR338, IR9V9, IR9W0, IR9W1, IRAR7, IRGT3, IRM85, IRMT2, IRMT3, IRX27, IRX28, IRZU1, IS222, IS587, IS884, IS885, ISC35, ISC36, ISEV3, ISIG5, ISIX3, ISJT6, ISJT7, ISRV3, ISRV4, ISTQ3, ISUA2, ISW51, ISZ85, IT154, IT3N8, IT4L0, IT5E8, ITAE3, IT7Z0, ITE21, ITE22, ITGI6, ITIV5, ITKA3, ITLB6, ITMA5, ITQS0, ITTT2, ITSH1, ITW64, ITYX8, IU2L4, IU3Z7, IU663, IUAM2, IUCR4, IUFH6, IUI14, IUKN4, IUN52, IUQL3, IUTA7, IUVY2, IUY66, IUZT0, IV1V3, IV43 and IV6A1.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060

Distribution

Distribution pattern: Worldwide distribution: USA including: CA,CO, FL, ID, IN, KS, NC, NH, NY, OH, PA, PR, SC, TN, and TX; and Country of: Canada.

Timeline

Recall initiated: 2011-01-14
Posted by FDA: 2011-03-17
Terminated: 2013-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.