Recall Z-0424-2013 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp.
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
| Date | Nov 21, 2012 (initiated Nov 2, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 a |
| Quantity | 263 cases of product. (2,630 devices) |
| Distribution | US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.