Actelion Phamaceuticals—Veletri Consumables Kit
What are the defects?
It has been identified that B. Braun water for injections from this lot may leak due to cracks in the neck of the bottle, which could result in bacterial contamination.
What are the hazards?
If the B. Braun water for injections 100 mL used to administer Veletri is contaminated with bacteria, there is a low risk of infection to the patient.
What should consumers do?
If you or someone you care for is taking Veletri, check their Veletri consumables kit to see if it comes from batch number 0309757 or 0309991.
If so, try to obtain an alternative water for injections product. If one is not available, do not stop taking Veletri. You can continue to use B. Braun water for injections 100 mL from lot 14217404 if you carefully inspect the bottle beforehand.
Check that the bottle appears to be full. Tip the bottle upside down and gently squeeze it to check for any leaks from the neck. Ensure the contents appear clear and colourless. If any leaks are observed, or if the water appears cloudy, discard the bottle and use a different one.
Please note that the risk of infection as a result of bacterial contamination of the B. Braun water for injections 100 mL from lot 14217404 included in your Veletri consumables kit is low. The potential impact of interrupting treatment with Veletri outweighs the risks associated with this issue.
If you have already used B. Braun water for injections 100 mL from lot 14217404 and did not notice any issues with the water or experienced any unusual symptoms after use, the risk of an infection is low.
If you have reconstituted cassettes in your fridge that contain B. Braun water for injections from the affected batch, you are advised to make a fresh lot of cassettes using an alternative water for injections product. If one is not available, and you did not notice any leakage or other signs of potential problems when you made up your cassettes, you can continue to use them as usual.
Once replacement Veletri consumables kits are received, you should immediately stop using any old kits that contain B. Braun water for injections 100 mL from lot 14217404.
If you have any questions or concerns, or feel unwell, contact your health professional. Alternatively, you can call Actelion Pharmaceuticals Australia on 1300 116 441.
Therapeutic Goods Administration is the responsible regulator for this recall.