| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00190-1 |
| Product Name/Description |
Mission Kit 16G x 10CM and Mission Kit 18G x 16CM
Lot numbers: 0001445630, 0001449980, 0001447513, 0001447513, 0001448121 and 0001450413
Catalog numbers: 1610MSK and 1816MSK
ARTG 302839
(Bard Australia Pty Ltd - Side-notch biopsy gun, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/03/2023 |
| Responsible Entity |
|
| Reason/Issue |
Bard (a BD Company) has determined that the Mission Kits from particular lots have a mismatch between the coaxial and the needle in the Mission Kit devices.
Device incompatibility due to the external diameter of the biopsy instrument being larger than the internal diameter of the coaxial needle is most likely to result in no patient involvement or a clinically insignificant procedural delay. If the coaxial needle has been deployed, despite incompatibility, unusual adverse events such as needle tip breakage may occur, and an additional device would be required. If a compatible device is not immediately available, the procedure may need to be repeated resulting in minor injury from a new needle puncture and care may be prolonged.
There have been no adverse events associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately review and quarantine inventory from the specific product code and lots. Customers should complete and return the Acknowledgement Form (supplied with the customer letter to impacted facilities) and dispose of affected stock.
Upon receipt of the Acknowledgement Form, BD will contact customers to arrange credit for impacted stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 656 100 - BD Customer Service |