Recall

Boston Scientific Corporation: Rapid Refill Continuous Injection System, UPN M00566001 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. Product details: Rapid Refill Continuous Injection System, UPN M00566001

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Agency
FDA
Record ID
Z-2725-2026
Canonical
https://claimwatch-mvp.vercel.app/item/boston-scientific-corporation-rapid-refill-continuous-injection-system-upn-m00566001/

What happened?

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 details: Rapid Refill Continuous Injection System, UPN M00566001

Who may be affected?

US Nationwide distribution. OUS consignee list pending.

What should consumers do?

Affected quantity: 153,921 (US); 119,274 (OUS)

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