Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
USMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
Recalling Firm: Medline Industries, LP
Motivo del Retiro / Peligro
TranslatedMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Descripción del Producto e Identificación
TranslatedMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
Productos Afectados
TranslatedMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98598 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25IBN161; Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25GBF769; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25HBN798; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25GBL527; Medline SKU VASC1198, UDI/DI each 10193489664263, UDI/DI case 40193489664264, Lot Number 25GDA142; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25IBP989; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25GBL526; Medline SKU VASCSLPON1, UDI/DI each 10889942405510, UDI/DI case 40889942405511, Lot Number 25GBL070. |
| Postal code | 60093-2753 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 1698 kits |
| Reason for recall | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260407 |
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 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syri...?
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 ResponsableMedline Industries, LP
- StatusOngoing
- Nivel de RiesgoClass I
- DistributionWorldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).
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🚨 SAFETY ALERT: Medline Industries, LP - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1. Check if your household is affected: https://therecallfile.com/es/recalls/medline-medical-convenience-kits-containing-namic-angiographic-rotatin/FDA-Z-1715-2026
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