Rapid Refill Continuous Injection System, UPN M00566001
USRapid Refill Continuous Injection System, UPN M00566001
Recalling Firm: Boston Scientific Corporation
Reason for Recall / Hazard
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
Product Description & Identification
Rapid Refill Continuous Injection System, UPN M00566001
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 99336 |
| Address 1 | 100 Boston Scientific Way |
| Code info | UDI-DI (GTIN) 08714729285151 Lots 33786611, 33825949, 33826026, 33949916, 33968571, 33968575, 34079981, 34153104, 34153413, 34153415, 34203075, 34203077, 34153411, 34203079, 34203115, 34386605, 34386609, 34386613, 34429656, 34429658, 34595249, 34693559, 34616613, 34616615, 34712433, 34763427, 34763967, 34805723, 34805725, 34805729, 35006995, 35006999, 35056793, 35208946, 35186845, 35208950, 35397314, 35208952, 35305436, 35498030, 35448316, 35498028, 35551523, 35626939, 35574463, 35688118, 35688460, 35828714,35831703, 35848483, 35877768, 35995282, 36049415, 36159194, 36219882, 36294100, 36303614, 36332230, 31177006, 31180206, 31666278, 31329922, 31356107, 31666276, 31798400, 31798133, 31798135, 31798137, 31852246, 32162450, 32208753, 32255526, 32255528, 32496142, 32661870, 32696046, 32696050, 32696052, 32752697, 32773682, 32791475, 32791477, 32820865, 32838612, 32791479, 33119798, 32977346, 32977348, 33030942, 33120320, 33158008, 33158006, 33354311, 33354315, 33354317, 33403248, 33403... [TRUNCATED] |
| Postal code | 01752-1234 |
| Report date | 20260722 |
| Product type | Devices |
| Product quantity | 153,921 (US); 119,274 (OUS) |
| Reason for recall | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260630 |
| Initial firm notification | Letter |
| Center classification date | 20260710 |
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Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution. OUS consignee list pending.
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🚨 SAFETY ALERT: Boston Scientific Corporation - Rapid Refill Continuous Injection System, UPN M00566001 Check if your household is affected: https://therecallfile.com/recalls/rapid-refill-continuous-injection-system-upn-m00566001/FDA-Z-2725-2026
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