FDA recall, , High risk
Windstone Medical Packaging Custom Convenience Kits with Medline Namic Angiographic Control Syringes
Custom Convenience Kits contain syringes whose rotating adapter can unwind during use, risking loose connection or disconnection.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc., of Billings, Montana, recalled 150 Custom Convenience Kits containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes). The syringes' manufacturer recalled them because the rotating adapter can unwind during use, which may result in a loose connection or full disconnection between syringe and manifold, leading to potential biohazard exposure, blood loss, infection, or air embolism.
The kits were distributed in Arizona. The company began the recall on April 2, 2026, and announced it on April 16, 2026. The FDA added the recall to its Enforcement Report on May 8, 2026, and it was in the weekly enforcement report on May 20, 2026.
What to do
If you have one of these products:
- Customers who have affected product(s) should immediately review their inventory and quarantine all affected kits.
- Contact the Quality Department for further instructions on labeling and replacement product if needed at 406-259-6387.
- You will be provided with a label that is to be placed on the packs containing the recalled Medline Namic Angiogrphic (RA) 10CC Syringe.
- Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled syringe. At the time the kit is opened for use any MEDLINE 10cc Syringe should be removed and destroyed. The recalled MEDLINE 10cc Control Syringe should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
- Brand
- Kit Name
- Aligned medical solutions
- Product Code
- Brand
- Angio Pack
- Aligned medical solutions
- AMS6908E
- Brand
- Angio Pack
- Aligned medical solutions
- AMS6908F
Label photos, 2
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Arizona.
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98741
- Recall number
- Z-2066-2026
- Quantity recalled
- 150 kits (US only)
All recalls from Windstone Medical Packaging, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Announced by the company
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
