Recall Z-1641-2014 ยท BTR Tube, Tracheal (W/Wo Connector)
Smiths Medical ASD, Inc.
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instill
| Date | Jun 11, 2014 (initiated Apr 10, 2014) |
| Status | Terminated |
| Reason | One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm. |
| Root cause | Packaging process control |
| Action | Smiths Medical sent an Urgent Medical Device Recall Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine all affected products and to complete the attached Response Form and return it to Smith Medical within 7 days of receipt of the notice. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at +1-800-258-5361. |
| Quantity | 100 devices |
| Distribution | US distribution in the state of North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790312 | ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR Respiratory Support Products, Inc., Feb 21, 1979 |