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U.S. Department of Health and Human Services

Class 2 Device Recall King Systems KLTD Oropharyngeal Airway

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  Class 2 Device Recall King Systems KLTD Oropharyngeal Airway see related information
Date Initiated by Firm January 14, 2011
Date Posted March 17, 2011
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-1707-2011
Recall Event ID 57970
510(K)Number K021634  K033186  
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product KING LTD, SIZE 5, 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 5: Large 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.
Code Information Product Code 10-0004, Lots: IHQ29, IHQX8, IIP84, IIQC0, IIQV1, IIRY1, IIT55, IIS67, IJJ82, IJJM2, II6M9, IK1E9, IK1E6, IJXN0, IJK97, IJ7J5, IJ744, IJ6E1, II2Y7, IK1E8, IK1E7, IK113, IJPD2, IL8Z1, IL8Z0, IL7P0, IL8Z2, ILRX5, ILRX6, IMST3, IMTI1, IMTV0, IMTW6, INER5, INF71, IP226, IP225, IP224, IPWK9, IQGH9, IQGZ5, IQHG9, IQIV1, IQTW3, IQTW4, IRI31, IRI30, IS874, IS875, ISP36, ISP49, ITLI3, IU0M2, IU0M3, IU0M4, IUE42, IUF30, IUF31, IUHJ4, IUHJ5, IUM87, IUM88, IUVA7, IUVA8, IUW25, IUYV7, IUZF8 and IV9V2.
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060
For Additional Information Contact Tony L. Barbour
317-776-6823
Manufacturer 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
FDA Determined
Cause 2		 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: 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAE and Original Applicant = KING SYSTEMS CORP.
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