Aligned Medical Angio Packs recalled due to Syringe Connection Risk, USA

United States

Aligned Medical Solutions 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. Aligned Medical Solutions distributed these kits nationwide in the United States. Recalled Product(s) were manufactured from 10/18/2024 to 11/13/2025 and distributed from 10/28/24 to 11/28/2025

Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit.

RECALLED PRODUCTS:

PRODUCT: Angio Pack
- Product codes: AMS6908E, AMS6908F
- DI numbers: B098AMS6908E0
- Lots: 214875

PRODUCT: Angio Pack
- Product codes: AMS6908F
- DI numbers: B098AMS6908F0
- Lots: 215436; 225001; 226706; 234088

These convenience kits contain the recalled Medline Namic Angiographic (RA) 10CC Syringe, Brand Name - Medline Medical Industries, part # 80085007.

This product has been recalled because Medline has identified, through post-market surveillance, a risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, and infection, as well as introduction of air into the line, which may result in air embolism - a condition that carries a serious injury or death. All units have the potential to exhibit this failure mode. There have been three instances reported to Medline of inadvertent air injection into the patient, and one instance of exposure to biohazard; none of these instances have resulted in death.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-namic