ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
USERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Recalling Firm: Erbe USA Inc
Grund für den Rückruf / Gefahr
TranslatedA strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
Produktbeschreibung & Identifikation
TranslatedERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Betroffene Produkte
TranslatedERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Additional Source Details
| Field | Value |
|---|---|
| City | Marietta |
| State | GA |
| Event id | 99341 |
| Address 1 | 2225 Northwest Pkwy SE |
| Code info | UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3 |
| Postal code | 30067-8764 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 11226 units |
| Reason for recall | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260626 |
| Initial firm notification | Letter |
| Center classification date | 20260812 |
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 ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000?
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 UnternehmenErbe USA Inc
- StatusOngoing
- RisikostufeClass II
- DistributionUS Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
📢 Warnung teilen
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Erbe USA Inc - ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 Check if your household is affected: https://therecallfile.com/de/recalls/erbecryo-2-cryosurgical-unit-model-catalog-number-10402-000/FDA-Z-2938-2026
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