United StatesHeraeus PALAMIX uno (Material No. 66057893; UDI‑DI 04260102133587; all batches with numbers below 223060) and PALAMIX duo (Material No. 66057897; UDI‑DI 04260102133617; all batches with numbers below 520215) are affected. Long‑term stability testing found the mixing rod may, in rare cases, come loose in units older than 1.5 years (17 months), and the shelf life is being reduced from 3 years to 1.5 years (17 months).
What's being recalled
Heraeus, PALAMIX uno. Material Number: 66057893.
Heraeus, PALAMIX duo. Material Number: 66057897.
Recalling firm: Heraeus Medical GmbH (Dental Division), Wehrheim, Germany.
How to identify it
Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060; Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
The hazard
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)