Recall Z-2595-2024 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 6
| Date | Aug 23, 2024 (initiated May 29, 2024) |
| Status | Open, Classified |
| Reason | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/29/2024 via letter. The notice explained the issue with the device, potential risk and requested the following: "Customer Required Actions: When using the device, all instructions, including warning and cautions contained in the Instructions for Use Documentation must be followed with heightened awareness. Please complete the following actions listed below: 1. Check all inventory locations within your institution for the affected catalog numbers listed in the notification and discontinue use. Discard all a |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies, Jun 19, 1991 |