No image published for this recall

No image published for this recall

Veletri Consumables Kit

Official notice

15 Feb 2016

Last checked

15 Feb 2016

Medium riskACCC

An official ACCC notice concerns Veletri Consumables Kit. 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. Published 2016-02-15.

What to do now

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.

Recall number

f3298f81-ee12-441b-b1ec-bee5a211a97b

Official notice

2016-02-15

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

14217404, may, 0309757, did, 0309991

Models

DESCRIPTION LOT NUMBER

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Affected products

Product 1

Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

medium

Recall details

Recall number

f3298f81-ee12-441b-b1ec-bee5a211a97b

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 15 Feb 2016. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.