Z-1706-2011

KING LTD, SIZE 4, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Carolina, 26950-4791...

Name: Z-1706-2011 KING LTD, SIZE 4, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Carolina, 26950-4791...
Creator: King Systems Corp.
Published: 2011-01-14
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2011-01-14 / Terminated / root cause: manufacturing process

FDA source

King Systems Corp. began a recall of KING LTD, SIZE 4, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King... on 2011-01-14. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1706-2011
Status: Terminated
Initiated: 2011-01-14
Posted: 2011-03-17
Terminated: 2013-02-20
Recalling firm: King Systems Corporation.
Product: KING LTD, SIZE 4, 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 4: Medium 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.
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 10-0003, Lots: IK022, IKM04, IKM06, IKM05, IKM07, IKM03, IK021, IK019, IK020, IK018, IK017, IK016, IK015, IK013, IK014, IJZX9, IJZB4, IJZ48, IJUK7, IJU57, IJTV5, IJK96, IJJM1, IIS66, IIRY0, IIQB9, IIJU9, IIJU8, IIJU7, IHQ28, IHP29, IHNK0, II7K4, II8B3, II5M4, II557, II401, II1F5, IHEH2, IHEH1, IH7A8, IJPD1, IJPS4, IJJ81, ILJT7, ILJT8, ILJT9, ILJU0, ILRX1, ILRX2, ILRX3, ILRX4, IM5H3, IM5W3, IM872, IMST2, IMTI0, IMTW5, IMTU9, IMUB7, INEQ9, INER0, INER1, INER2, INER4, INER3, INU73, INU74, IP222, IP223, IPD19, IPD20, IPD21, IPWF7, IPZ81, IQ3Z1, IQ864, IQ865, IQBU4, IQC94, IQDP1, IQDP2, IQGZ4, IQHG8, IQTW0, IQTW1, IQTW2, IRI29, IRV93, IRV94, IRZR8, IS0D7, IS869, IS870, IS871, IS872, ISP35, ISP34, IT8F5, IT8F6, ITGP8, ITGP9, IU0M0, IU0M1, IU0Q7, IU0Q8, IU975, IU976, IU977, IU978, IU979, IUF29, IUFK9, IUM83, IUM84, IUM85, IUM86, IUSH1, IUS79, IUVA6, IUW24, IV063, IV064, IV065, IV066, IV5M1, IV5M2 and IV5M3.

Product code CAE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)