| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00918-1 |
| Product Name/Description |
Covidien Shiley Hi-Contour and Low-Contour Oral/Nasal Tracheal Tubes Cuffed.
Multiple Model Numbers, Products and Lot Numbers
ARTG 179891 (Medtronic Australasia Pty Ltd - Tube tracheal general-purpose single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2022 |
| Responsible Entity |
|
| Reason/Issue |
A shipment of Medtronic Endotracheal Tubes was inadvertently consolidated into a container alongside cargo originating from a high risk country for Brown Marmorated Stink Bug (BMSB). Under Australian customs law, the entire container was mandated to undergo fumigation with Methyl Bromide or Sulfuryl Fluoride to prevent importation of BMSB.
The Endotracheal Tubes are provided in sterile packaging however, without testing the devices, Medtronic do not know if the vapours from these fungicides have penetrated the packaging.
Medtronic is requesting all product from the lots listed above be immediately quarantined and returned to Medtronic due to this issue. Medtronic will carry out investigations to determine if any of the fumigant was able to pass through the product’s sterile packaging. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to:
• Immediately identify and quarantine all affected products listed.
• Complete the Customer Confirmation Form provided by Medtronic and return to rs.anzrecalls@medtronic.com.
• Please share the recall notice to all those who need to be aware within your organization or to any organization where the affected product has been transferred.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0402 897 410 - James Woodin (Medtronic) |