Recall Z-1714-2011 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp.
KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2, 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
| Date | Mar 17, 2011 (initiated Jan 14, 2011) |
| Status | Terminated |
| 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 lubric |
| Quantity | 577,426 total units |
| 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. |
| FDA record | Open on fda.gov |