United StatesEdermy LLC is recalling the PIE Trolley System Model 2005 and PIE PAK models P2HC‑A, P2HC‑S and P2HC (all lots, UDI) distributed nationwide in the United States in OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX and CO; the notice lists 27 units and 11,202 units. They were recalled because they lack 510(k) clearance.
What's being recalled
PIE Trolley System Model: 2005
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Recalling firm: Edermy LLC, Pendergrass, GA, United States.
How to identify it
All Lots All Lots UDI:
The hazard
Lack of 510K clearance
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 OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.
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)