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U.S. Department of Health and Human Services

Class 2 Device Recall KING LAD SILI CONE

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  Class 2 Device Recall KING LAD SILI CONE see related information
Date Initiated by Firm November 02, 2012
Date Posted November 21, 2012
Recall Status1 Terminated 3 on May 28, 2013
Recall Number Z-0421-2013
Recall Event ID 63580
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile
Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg

Product Usage:
Laryngeal airway
Code Information REF: LAD-305, Lot #K120620 and Lot #K120406
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060
For Additional Information Contact
317-776-6823
Manufacturer Reason
for Recall		 The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
FDA Determined
Cause 2		 Nonconforming Material/Component
Action King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.
Quantity in Commerce 263 cases of product. (2,630 devices)
Distribution US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
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.
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