Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
USSurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Recalling Firm: SUREPULSE MEDICAL LTD
Grund für den Rückruf / Gefahr
TranslatedRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Produktbeschreibung & Identifikation
TranslatedSurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Betroffene Produkte
TranslatedSurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Additional Source Details
| Field | Value |
|---|---|
| City | Nottingham |
| State | N/A |
| Event id | 98292 |
| Address 1 | Medicity D6 Thane Road |
| Address 2 | N/A |
| Code info | DI Number: 05060550650044/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001 |
| Postal code | N/A |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | N/A |
| Reason for recall | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20230120 |
| Initial firm notification | N/A |
| Center classification date | 20260212 |
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 Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor?
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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Übersicht
- Rückrufendes UnternehmenSUREPULSE MEDICAL LTD
- StatusOngoing
- RisikostufeClass III
- DistributionWorldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
📢 Warnung teilen
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: SUREPULSE MEDICAL LTD - Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor Check if your household is affected: https://therecallfile.com/de/recalls/surepulse-vs-cap-extra-large-ref-sp-163-a1-component-of-vs-newborn-hea/FDA-Z-1360-2026
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