PIE PAK Models: P2HC-A, P2HC-S, P2HC
USPIE PAK Models: P2HC-A, P2HC-S, P2HC
Recalling Firm: Edermy LLC
Motivo del Retiro / Peligro
TranslatedLack of 510K clearance
Descripción del Producto e Identificación
TranslatedPIE PAK Models: P2HC-A, P2HC-S, P2HC
Productos Afectados
TranslatedPIE PAK Models: P2HC-A, P2HC-S, P2HC
Additional Source Details
| Field | Value |
|---|---|
| City | Pendergrass |
| State | GA |
| Event id | 98303 |
| Address 1 | 115 Enterprise Dr Ste A |
| Address 2 | N/A |
| Code info | All Lots UDI: |
| Postal code | 30567-4701 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 11202 units |
| Reason for recall | Lack of 510K clearance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260114 |
| Initial firm notification | |
| Center classification date | 20260224 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought PIE PAK Models: P2HC-A, P2HC-S, P2HC?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableEdermy LLC
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.
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🚨 SAFETY ALERT: Edermy LLC - PIE PAK Models: P2HC-A, P2HC-S, P2HC Check if your household is affected: https://therecallfile.com/es/recalls/pie-pak-models-p2hc-a-p2hc-s-p2hc/FDA-Z-1462-2026
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