Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating Adaptor Control Syringes

This recall involves removing 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.  

Affected Product

The FDA is aware that Medline Industries has issued an Urgent Medical Device Recall to affected customers recommending all Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits containing RA Syringes be removed from where they are used or sold. Affected devices:

• Namic Angiographic Rotating Adaptor (RA) Control Syringes
• Convenience Kits containing Namic Angiographic Rotating Adaptor (RA) Control Syringes  

Full list of affected products.

What to Do

Remove and destroy all Namic RA Syringes. Apply over-labels to all affected kits on hand stating that the affected syringes must be removed and discarded from further use.  

On February 27, Medline Industries sent all affected customers an Urgent Medical Device Recall notice recommending the following actions:

• Immediately check your stock for any affected product and quarantine. Destroy affected product after completing recall response forms.
• Apply provided over-labels to any affected kits on hand stating that the affected syringes must be removed and discarded from further use.
• If you are a distributor or have resold or transferred this product, notify them of this recall communication.
• In rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk, the Namic RA syringe may be used with extreme caution and vigilance.
  • Precautions include manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure.  Strict adherence to all usage guidelines and the Instructions for Use is also required.
  • 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.

Reason for 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

The Namic Angiographic Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.  

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline Industries at recalls@medline.com or 866-359-1704.

Additional FDA Resources  

1. FDA Enforcement Report
2. CDRH Medical Device Recall Database  

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.