King Systems Corp.: KING LTS-D, SIZE 3, QUANTITY 5 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 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.

Recall number

Z-1708-2011

Recalling firm

King Systems Corp.

Product

KING LTS-D, SIZE 3, QUANTITY 5 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 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.

Status

Terminated

Initiated

2011-01-14

Posted

2011-03-17

Terminated

2013-02-20

Reason

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

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.

Quantity

not on file

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.

Lot, serial or model codes

Product Code 10-0025, Lots: IPNV9, IPTA6, IPTA7 and IQGI0.

510(k) numbers

["K021634","K033186"]

PMA numbers

not on file

Product code

CAE

Firm FEI

1824226

Firm city

Noblesville

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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