Recall Z-0228-05 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD, Inc.
Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000
| Date | Nov 24, 2004 (initiated Sep 9, 2004) |
| Status | Terminated |
| Reason | Sterility of the device is compromised due to packaging defects |
| Root cause | Other |
| Action | Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252. |
| Quantity | 3,130 all decannulation caps |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |