Edermy LLC: PIE Trolley System Model: 2005
Read the official notice at FDA (device) →
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 Trolley System Model: 2005
- 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
- Product quantity
- 27 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Pendergrass
- State
- GA
- Country
- United States
- Event id
- 98303
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