| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00835-1 |
| Product Name/Description |
Of Spiggle & Theis PTFE Ventilation Tubes
Article Numbers: 104100, 104115, 104125
Multiple batch numbers affected
ARTG Number: 182921 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Spiggle & Theis Medizintechnik GmbH Internal routine checks discovered that the weld seam of the blister packaging might be incomplete in the area of the pull tab.The weld seam around the blister cavity might show a visually inconsistent blue colouring. This may impair the sterility of the product.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CoreMed is advising their customers not to use the blisters where the sterile barrier appears to be impaired i.e., the weld seam of the blister packaging might be incomplete in the area of the pull tab and return them to CoreMed. CoreMed will replace the affected products. This action has been closed-out on 02/06/2016. |
| Contact Information |
02 9810 6947 - CoreMed Pty Ltd |