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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63580
Product Type Devices
Status Ongoing
Recalling Firm King Systems Corp.
City Noblesville
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-02
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0418-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0419-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0420-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0421-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0422-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0423-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0424-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0425-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0426-2013
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 Class II 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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices. 263 cases of product. (2,630 devices) Z-0427-2013
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