Recall Z-0269-2016 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Instrumentation Industries Inc
Ventilator Tubing
| Date | Sep 23, 2015 |
| Status | Terminated |
| Reason | As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage |
| Root cause | Nonconforming Material/Component |
| Action | Instrumentation Industries notified consignees by e-mail and telephone of the recall. The firm also sent a Notice of Product Recall letter dated September 23, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to determine if they have any of the affected product and contact the firm to make arrangements for return to Instrumentation Industries, Inc. Replacement product will be sent as soon as possible after all quality inspections have been completed. If product was further distributed consi |
| Quantity | 567 |
| Distribution | Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.