FDA-Device2026-05-20Class IPROCESSING DEFECT

Windstone Medical Packaging Custom Convenience Kit recalled for defective Medline Namic angiographic syringes

OTHERNationwide distribution

Windstone Custom Convenience Kit recalled for syringe disconnection risk

Windstone Medical Packaging's Custom Convenience Kit (Angio Pack, part numbers AMS6908E and AMS6908F) contains Medline Namic angiographic syringes with a defect: the rotating adapter can unwind during use, causing the syringe to loosen or fully disconnect from the manifold. This disconnection could expose patients to biohazard contamination, blood loss, infection, or air embolism.

  • Stop using affected kits immediately if you have part numbers AMS6908E or AMS6908F.
  • Contact Windstone Medical Packaging or the manufacturer for instructions on how to return or dispose of the kits.
  • Review patient records if these kits were used, and monitor patients for any adverse effects.
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.

Sold states
US Nationwide distribution in the state of Arizona.
Affected count
150 kits (US only)
Manufactured in
1602 4th Ave N, Billings, MT, United States
Products
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2066-2026

Also reported as

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