Recall Z-2066-2026— Windstone Medical Packaging, Inc.
Class I · Ongoing
Class I FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2026-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F. 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..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-04-02
- Firm location
- Billings, MT, United States
Product description
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.