Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack
Aligned Medical Solutions (dba Windstone Medical Packaging) initiated a nationwide recall of AMS6908E and AMS6908F Angio Pack convenience kits. The recall is due to the inclusion of the Medline Namic Angiographic Rotating Adapter (RA) 10CC Syringe within these specific kits.
This recall affects Aligned Medical Solutions, distributors of specialized Angio Packs, and healthcare facilities utilizing these kits in cardiac or vascular procedures. Quality and supply chain departments at the clinical level are directly impacted.
The recall of a component within a convenience kit necessitates the withdrawal of the entire assembly, potentially causing procedural delays in catheterization or angiography suites. Regulatory and QA teams should note that while the syringe is the primary concern, the kit manufacturer is responsible for executing the recall of the aggregate product. This underscores the risk associated with bundling third-party components into sterile convenience packs.
Identify and sequester AMS6908E and AMS6908F kits within the supply chain. Quality teams should conduct a reconciliation of inventory against the manufacturer's recall notice and prepare to facilitate the return or replacement of affected components. Clinical departments must ensure these specific syringes are not used in active procedures.
On April 02, 2026, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of two convenience kits that contain the Medline Namic Angiographic Rotating Adapter(RA) 10CC Syringe. Associated kits are AMS6908E Angio Pack and AMS6908F Angio Pack.
Open in openFDA / FDA.gov