Recall - Aligned Medical Angio Pack (Angio Packs (AMS6908E and AMS6908F)) produced by Windstone Medical Packaging dba Aligned Medical Solutions - Risk of the syringe rotating[...]

Summary

Company Announcement

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.

Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Product labels can be viewed at the following link. Click Here.

Recalled products include:

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, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=219145

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

No injuries have been reported to Aligned Medical Solutions to date.

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. Customers 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. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement syringes if requested.

Customers with questions may contact the company via telephone at 1-800-360-9428 between the hours of 8:00 am and 5:00 pm (Mountain Time). Customers may also contact the company via email at [email protected].

Please contact Vicki Davis at [email protected] for replacement product or via telephone 406-259-6387 between the hours of 8:00 am and 5:00 pm (Mountain Time)..

Aligned Medical Solutions has notified the FDA of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting via:

• Complete and submit the report: Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178