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Recall Observatory FDA recall evidence

Device product

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

Z-2066-2026

April 02, 2026

Class I

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 98741
Status
Ongoing
Classification
Class I
Quantity
150 kits (US only)
Official record key
device-enforcement:Z-2066-2026

Official wording

Reason: 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.

Code information: Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088

Distribution pattern: US Nationwide distribution in the state of Arizona.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.