Aligned Medical AMS16835 Fluids Kit RX
USAligned Medical AMS16835 Fluids Kit RX
Recalling Firm: Windstone Medical Packaging, Inc.
Motivo del Retiro / Peligro
TranslatedLidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Descripción del Producto e Identificación
TranslatedAligned Medical AMS16835 Fluids Kit RX
Productos Afectados
TranslatedAligned Medical AMS16835 Fluids Kit RX
Additional Source Details
| Field | Value |
|---|---|
| City | Billings |
| State | MT |
| Event id | 98957 |
| Address 1 | 1602 4th Ave N |
| Code info | UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935 |
| Postal code | 59101-1521 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 875 kits |
| Reason for recall | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260603 |
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 Aligned Medical AMS16835 Fluids Kit RX?
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 ResponsableWindstone Medical Packaging, Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS Nationwide distribution in the states of IL, VA.
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🚨 SAFETY ALERT: Windstone Medical Packaging, Inc. - Aligned Medical AMS16835 Fluids Kit RX Check if your household is affected: https://therecallfile.com/es/recalls/aligned-medical-ams16835-fluids-kit-rx/FDA-Z-2307-2026
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