Windstone Medical Packaging, Inc.: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pa
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Windstone Medical Packaging, Inc.
- Product
- Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the state of Arizona.
- Recall initiated
- 2026-04-02
- Code info
- Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
- Product quantity
- 150 kits (US only)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Billings
- State
- MT
- Country
- United States
- Event id
- 98741
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