CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that American Contract Systems has issued a letter to affected customers recommending certain angiographic syringes included in convenience kits be removed from where they are used or sold. Affected devices:
Device Description | Model/Item Number | Unique Device Identifier | Lot Number |
|---|---|---|---|
Coronary Angio Pack | ANCA80AQ | 191072236678 | 42-8207211 |
Coronary Angio Pack | ANCA80AP | 42-8146111 |
What to Do
Identify kits with affected syringes. Apply over-labels to all affected kits on hand stating that the affected syringes must be removed and discarded from further use.
On March 19, American Contract Systems sent all affected customers a letter recommending the following actions:
- Identify, segregate, and quarantine all affected product.
- Add warning labels to all affected kits stating that the affected syringes must be removed and discarded from further use.
- Use the labeling template provided by American Contract Systems to print labels. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.
- If you are a distributor or have resold or transferred this product, notify them of this recall communication.
- Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure.
- All usage guidelines and the Instructions for Use are provided in Medline’s recall letter. Strict adherence to all usage guidelines and the Instructions for Use are required.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
American Contract Systems initiated an urgent Medical Device Recall notification for Coronary Angio Pack convenience kits that contain syringes affected by Medline’s Namic Angiographic Control Syringes with Rotating Adaptor (“Namic RA Syringes”) recall.
Medline Industries stated that the syringe rotating adaptor on affected devices may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold. If unwinding occurs, there is potential for biohazard exposure, blood loss, and infection. Loose connections or disconnections may introduce air into the line, which could result in air embolism. These conditions may lead to serious injury or death. All units have the potential to exhibit this failure mode.
As of March 13, Medline Industries has reported four serious injuries and no deaths associated with this issue.
Device Use
Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medical Action Industries at complaints@owens-minor.com .
Additional FDA Resources
- Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating Adaptor Control Syringes | FDA [04/09/2026]
- FDA Enforcement Report for Medline Namic RA Syringes Recall
- CDRH Medical Device Recall Database for Medline Namic RA Syringes Recall
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.