| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00874-1 |
| Product Name/Description |
Flexi-Slip endotracheal tube stylets
(Intended for use in facilitating intubation of tracheal tubes.)
SAP/Catalogue Number: 502501-000060
Batch Numbers: 14BG27, 14FG03
ARTG Number: 214058 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. This may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia.
Over 200,000 units have been distributed and there have been 4 complaints to August 2015. This gives rise to a complaint rate of 0.00205%.
No patient injuries have been reported related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect their stock, quarantine any affected units from use and to follow the instructions on the acknowledgement form in order to have those units collected. An appropriate account credit will then be issued. This action has been closed-out on 22/08/2016. |
| Contact Information |
1300 360 226 - Customer Service |