| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00656-1 |
| Product Name/Description |
Laryngeal Tube Set – size 4 (LTS-D S4 Adult)
Item code: 32-06-104-1
Lot Number: A-04505
ARTG Number: 163221 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified where size 5 laryngeal tubes have been inadvertently packaged in size 4 Laryngeal Tube Set packs. The tubes within the pack are correctly labelled as size 5 and this information is visible through the packaging. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are asked to quarantine and discontinue use of the affected item code and lot listed in the customer letter and to follow the instructions given when returning the goods. If your facility has distributed the affected products to other persons or facilities, customers are also asked to promptly forward a copy of the recall letter to those recipients. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 9429 3108 - Medtronic |