United StatesEWO_02512 (catalog 320550) Nano Pro Un‑Cannulated demo samples and EWO_02513 (catalog 320122) Nano Un‑Cannulated demo samples, both labeled “For Investigational Use Only,” are affected; they were distributed across many U.S. states. They were recalled because pen needles labeled for investigational use were inadvertently distributed as commercially marketed devices.
What's being recalled
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Recalling firm: embecta Medical II LLC, Parsippany, NJ, United States.
How to identify it
No UDI/All products labeled "for Investigational Use Only"
The hazard
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
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
US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.
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)