FDA DeviceClass INotable

FDA Recall: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating

Date: 2026-05-20
Brand: Windstone Medical Packaging, Inc.
Category: Medical Device
FDA Class: Class I

Description

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

Hazard

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

Remedy

150 kits (US only)

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