| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00461-1 |
| Product Name/Description |
BLUselect Tracheostomy Tube Kits, BLUselect Suctionaid Tracheostomy Tube Kits, BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Forceps, BLUperc Dilation Procedural Tray with Single Stage Dilator Products, BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube
Multiple lot numbers and product descriptions
ARTGs: 328560 & 397290 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products.
If the pilot balloon used to inflate the tracheostomy cuff becomes detached from the inflation line, the cuff pressure may not be maintained which can lead to inadequate ventilation of, and increased risk of aspiration to the patient.
To date, Smiths Medical has received 13 reports of serious injury and zero (0) deaths associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Check all inventory for the affected lots and discontinue use.
- Discard/destroy all affected stock following institutional processes.
- If discarding is not immediately possible then the product should be quarantined until it can be disposed/destroyed.
- Smiths Medical will issue a credit once the customer acknowledgement form is received outlining how many devices have been destroyed.
If the device is currently in-situ for a patient currently being ventilated, the clinician should consider the risks and benefits of leaving the device in situ versus explantation and exchange for an alternative product.
If, due to extenuating circumstances, an alternative device cannot be used, all instructions, including warnings and cautions contained in the Instructions for Use Documentation must be followed with heightened awareness when checking the device prior to use and while in use. |
| Contact Information |
1800 654 949 - Smiths Customer Service |