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Edermy LLC: PIE PAK Models: P2HC-A, P2HC-S, P2HC

Medical DevicesSource: FDA (device) · Date: 2026-03-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Edermy LLC
Product
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Reason / hazard
Lack of 510K clearance
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-01-14
Code info
All Lots UDI:
Product quantity
11202 units
Voluntary mandated
Voluntary: Firm initiated
City
Pendergrass
State
GA
Country
United States
Event id
98303
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