| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00412-1 |
| Product Name/Description |
Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
Neonatal
-Tracheostomy Tube Cuffless
2.5NEF, 3.0NEF, 3.5NEF, 4.0NEF & 4.5NEF
-Tracheostomy Tube with TaperGuard Cuff
2.5NCF, 3.0NCF, 3.5NCF
Pediatric
-Tracheostomy Tube Cuffless
2.5PEF, 3.0PEF, 3.5PEF, 4.0PEF, 4.5PEF, 5.0PEF, 5.5PEF
-Tracheostomy Tube Long Cuffless
5.0PELF, 5.5PELF, 6.0PELF, 6.5PELF
All lot numbers beginning with 12, 13 and 14 & 15A0152JZX & 15A0154JZX |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Covidien is conducting this recall following reports from customers where patients who recently switched from the current Shiley Neonatal and Pediatric products to these affected products as listed above, experienced discomfort immediately after the switch in a limited number of situations. In some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch. In all reported cases, patients were administered immediate medical attention. Serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. There have been 12 reports of serious injuries. No deaths have been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Covidien is requesting hospitals to discontinue use and quarantine all affected devices. Covidien will organise for the recovery of the affected devices.
If one of the recalled Shiley tracheostomy tubes is currently in use in a patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, Covidien recommends that the patient’s physician evaluate the continued use.
This recall was finalised on 11/09/2018 |
| Contact Information |
02 9418 9611 - Covidien Pty Ltd |