The Recall Desk

FDA (Devices) recall action 63580

King Systems Corp. recalled 10 products on 2012-11-28

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products
10
Announced
2012-11-28
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–10 of 10

  • HighFDA (Devices)··2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.

    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
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure

    King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.

    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
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2012-11-28

    King Systems Recalls Child Silicone Laryngeal Airway Devices Due to Sterilization Indicator Defect

    King Systems Corp. is recalling 2,630 child silicone laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper EtO sterilization.

    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
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2012-11-28

    King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.

    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
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2012-11-28

    King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to sterilization indicators that failed to change color as expected.

    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
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2012-11-28

    King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of adult silicone King LAD devices because sterilization indicators failed to change color as expected.

    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
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper sterilization.

    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
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2012-11-28

    King Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling 2,630 infant laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper ethylene oxide sterilization.

    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
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2012-11-28

    King Systems Recalls Infant Silicone Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 infant silicone laryngeal airway devices due to potential EtO sterilization indicator failures.

    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
    Category
    Distribution
    11 states