Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. This is an update to an Early Alert; the affected products have not changed. Recommendations for what to do with the devices below have been updated.

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   42-8267711   42-8311311   42-8337611   42-8353311   42-8379211   42-8407111   42-8510711   42-8575111   42-8611511   42-8718911   42-8718912   42-8722611   42-8805311   42-8820611   42-8870911
Coronary Angio Pack	ANCA80AP	00191072232168	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 a letter notifying all affected customers of this issue. On April 21, a revised notification was sent to affected customers. These notifications recommend 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 your facility used the labeling template provided with the initial letter, please adhere the revised label over the existing template label. 
• 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.
• If use is unavoidable, be prepared to follow the additional instructions provided in the Urgent Medical Device Recall notice if the syringe unwinds and causes a loose connection or disconnection during procedural setup or during the 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. 

Reason for Recall

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  

1. Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating Adaptor Control Syringes | FDA [04/09/2026]   
2. FDA Enforcement Report
   1. American Contract Systems Convenience Kit Recall
   2. Medline Namic RA Syringes Recall
3. CDRH Medical Device Recall Database
   1. American Contract Systems Convenience Kit Recall
   2. 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.

Timeline of Communication Updates

Date	Actions
05/07/2026	The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall and make changes to the “What to do” section in line with the updated customer notification.
04/16/2026	The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.