- Iradimed Corporation (NASDAQ:IRMD) notified a potential issue with some 1057 Syringe Adapter Sets related to the syringe venting function during use.
- The company designs, manufactures, markets, and distributes MRI-compatible medical devices, accessories, disposables, and related services.
- The issue can lead to reduced flow with the MRidium infusion pump resulting in subsequent inlet occlusion and alarm indication.
- The 1057 Syringe Adapter Set is an IV fluid administration set with a vented syringe adapter (disposable tubing), which allows for the delivery of IV fluids from syringes while on the company’s infusion pump.
- Also Read: Iradimed Withdraws FDA Application For Updated MR IV Pump System.
- The customer notification, which outlines the potential risks associated with the 1057 Syringe Adapter Set, lists the affected products.
- The updated labeling provides specific actions users should take to identify any venting and infusion delivery issues before an unexpected inlet occlusion occurs.
- Iradimed received five customer complaints of an unexpected inlet occlusion alarm resulting in the infusion being stopped, none of which were associated with injuries or death.
- Upon investigation, the company identified a defective injection molded part that can limit the effectiveness of the syringe vent and result in this condition in an estimated 0.4% of recently manufactured 1057 infusion sets.
- No other of the company’s IV sets or disposables are involved, and the company does not expect any material financial impact from this action.
- Price Action: IRMD shares closed higher by 0.16% at $37.48 on Friday.
Boeing CEO Dave Calhoun To Meet Ted Cruz And Other Senators Over 737 MAX 9 Grounding
Boeing CEO Dave Calhoun will meet with U.S. Senators Ted Cruz and Mark Warner to address concerns about the recent grounding of the 737 MAX 9 after a cabin panel blowout incident. Senators, including Maria Cantwell, plan to discuss safety issues and the future of MAX 10 orders.
