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 | |
| 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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