GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
USGLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Recalling Firm: Terumo Medical Corporation
Grund für den Rückruf / Gefahr
TranslatedProduct was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Produktbeschreibung & Identifikation
TranslatedGLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Betroffene Produkte
TranslatedGLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Additional Source Details
| Field | Value |
|---|---|
| City | Elkton |
| State | MD |
| Event id | 99285 |
| Address 1 | 950 Elkton Blvd |
| Code info | Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871. |
| Postal code | 21921-5322 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 7,490 units |
| Reason for recall | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260615 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260810 |
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 GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to...?
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 UnternehmenTerumo Medical Corporation
- StatusOngoing
- RisikostufeClass II
- DistributionWorldwide distribution - US Nationwide and the country of Canada.
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Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Terumo Medical Corporation - GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. Check if your household is affected: https://therecallfile.com/de/recalls/glidesheath-slender-a-kit-6f-10cm-021gw-5-units-per-box-product-code-6/FDA-Z-2930-2026
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