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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

King Systems Corp.: 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

Agency Publication Date: November 21, 2012
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Affected Products

Product: KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

REF: LAD-302, Lot #K120501

Lot Numbers:
K120501
Product: KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

REF: LAD-303, Lot #K120618

Lot Numbers:
K120618
Product: KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg

REF: LAD-304, Lot #K120619

Lot Numbers:
K120619
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

REF: LAD-305, Lot #K120620 and Lot #K120406

Lot Numbers:
K120620
K120406
Product: KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

REF: LAD-703, Lot #K120411

Lot Numbers:
K120411
Product: KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

REF: LAD-704, Lot #K120412

Lot Numbers:
K120412
Product: KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

REF: LAD-705, Lot #K120413

Lot Numbers:
K120413
Product: KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

REF: LAD-902, Lot #K120414

Lot Numbers:
K120414
Product: KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

REF: LAD-903, Lot #K120416

Lot Numbers:
K120416
Product: KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

REF: LAD-904, Lot #K120417

Lot Numbers:
K120417

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 63580
Status: Resolved
Manufacturer: King Systems Corp.
Manufactured In: United States
Units Affected: 10 products (263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices); 263 cases of product. (2,630 devices))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.