| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01000-1 |
| Product Name/Description |
Various Tissu-Trans Products
Mega Trans 1500
Model Number: SH 3-TT-1500
Lot Numbers: 61288, 61464
Tissu Trans 100cc
Model Number: SH 3-TT-FILTRON 100
Lot Numbers: 12018, 12109
Tissu Trans 1000
Model Number: SH 3-TT-FILTRON 1000
Lot Numbers: 12004, 61235
Tissu Trans 250
Model Number: SH 3-TT-FILTRON 250
Lot Numbers: 12019, 61286, 61421
Filtron 500
Model Number: SH 3-TT-FILTRON 500
Lot Numbers: 12002, 12046, 61363
ARTG Number: 181259 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Results from a visual examination performed on the packaging by the manufacturer Shippert Medical Technologies has revealed that the seal integrity of specific Tissu-Trans product sterile packages cannot be assured prior to usage without a visual inspection of the seal.
To date, Shippert has not received any customer complaints or reports of serious injuries and/or deaths due to the lack of sterility. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Remove all affected products and store them in a separate area. These products must not come into clinical use.
2. Forward this letter to all staff members that need to be aware of this information letter and the initiated recall.
3. Contact Precise medical supplies customer service for any additional questions regarding return of the products.
4. Replacement product will be issued and sent for returned products.
This action has been closed out on 11/07/2019 |
| Contact Information |
1300 659 410 - Precise Medical |