Rapid Refill Continuous Injection System, UPN M00566001
Boston Scientific Corporation
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Rapid Refill Continuous Injection System, UPN M00566001
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI (GTIN) 08714729285151 Lots 33786611Model 33825949Model 33826026Model 33949916Model 33968571Model 33968575Model 34079981Model 34153104Model 34153413Model 34153415Model 34203075Model 34203077Model 34153411Model 34203079Model 34203115Model 34386605Model 34386609Model 34386613Model 34429656Model 34429658Model 34595249Model 34693559Model 34616613Model 34616615Model 34712433UPC 08714729285151Would you have heard about this one?
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