Medical Angiographic Control Syringes Recalled for Rotating Adapter Risk
Windstone Medical Packaging is recalling Custom Convenience Kits containing Medline Namic Angiographic Control Syringes due to risk that the rotating adapter may unwind during use, potentially causing disconnection and exposure to biohazards, blood loss, infection, or air embolism.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device with serious harm potential. The source identifies risks of biohazard exposure, blood loss, infection, and air embolism—serious adverse health consequences—meeting the Severe threshold per the rubric.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 150 Custom Convenience Kits containing Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack distributed nationwide in Arizona. The affected product part numbers are AMS6908E and AMS6908F.
The recalled syringes pose a risk that the rotating adapter may unwind during use. If unwinding occurs, the connection between the syringe and manifold may loosen or separate completely. This disconnection creates potential for biohazard exposure, blood loss, infection, or air embolism.
Consumers using these syringes should stop use immediately. Contact Windstone Medical Packaging, Inc. or Medline for further guidance on replacement or disposal of affected kits. Recall number Z-2066-2026 can be referenced when seeking assistance.
The recalled product
- Product
- Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 225001
- 226706
- 234088
Distribution
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