| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01169-1 |
| Product Name/Description |
300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
Part number M8275059/5
Lot Numbers: 2590876 (expiry date 11/2016) and 2590877 (expiry date 01/2017)
ARTG Number: 226774 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing has revealed the potential for small holes the size of a pin to develop in the pouches of the sterile canisters. If these small holes occur and the canister is used in a sterile field, there is a potential for contamination.
To date, there have been no complaints regarding damaged packaging or reports of any patient injuries or complications due to potentially non-sterile canisters. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising the users to inspect stock and quarantine the affected units prior to their return. Alternatively, users can continue to use the affected devices provided that the tubing cap remains in the tubing until use and the canister is used outside of the operating room's sterile field. This action has been closed-out on 26/08/2016. |
| Contact Information |
02 9422 4322 - KCI |