Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.
The company’s Namic angiographic rotating adaptor control syringes are used to administer radiographic contrast media in medical imaging. The syringes may unwind during use, potentially leading to biohazard exposure for clinicians, and blood loss and infection for patients. The problem can also cause air to be introduced into the line, potentially leading to an air embolism, a life threatening condition where an air bubble blocks blood flow.
As of March 13, Medline had reported four serious injuries and no deaths associated with the issue, according to the FDA recall notice.
Medline, a Northfield, Illinois-based manufacturer and distributor of medical supplies, sent a letter to customers on Feb. 27 instructing them to destroy and quarantine the affected devices.
In rare cases where angiography is urgently required and no alternative device is available, clinicians may use the Namic rotating adaptor syringe “with extreme caution and vigilance,” according to the FDA notice.
Clinicians who use the device in these circumstances must manually stabilize syringe-to-manifold connections and monitor the device during the entire procedure.
Excess silicone identified, cleaning problems documented
Medline received the warning after the FDA inspected its Glen Falls, New York, facility, where it makes the Namic product line, in December.
FDA investigators found that Medline did not take actions commensurate with the risk of the syringe problems.
In June 2023, Medline started a corrective action plan after receiving reports that the syringes could disconnect from manifolds, according to the warning letter. The company attributed the problem to the presence of excess silicone. Medline had received complaints including a report of injection of air into a patient and biohazard exposure for a clinician, according to the warning letter.
Medline initially determined that the health risk of the product was low. In January, after the FDA’s inspection findings, the company responded by scrapping affected devices in its inventory and increasing the cleaning frequency of a machine to prevent excess silicone.
Medline proposed that a field notice was appropriate instead of a full product removal, “given the effectiveness of prior communications, the upcoming alternative solution, and prevention of a market shortage.”
A month later, Medline developed a revised plan to remove the syringes, following multiple discussions with the FDA about its recall strategy. The company received 250 complaints related to the problem between June 2023 and Feb. 19, 2026, according to the warning letter.
Medline also reviewed its cleanroom manufacturing risks to identify opportunities for improvement after an FDA investigator observed accumulated particulates on top of manufacturing machines. However, the company did not assess the field impact and inventory for products manufactured in those cleanrooms.
The last documented cleaning of equipment tops in the cleanrooms prior to the inspection was Nov. 26, 2023, and Medline had received 114 complaints of foreign matter or hair since that date, according to the warning letter.
