Medical Device Safety
The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi.
The Food and Drug Administration has identified a Class I recall of Medtronic Aortic Root Cannulas due to a risk of unexpected loose material in the male luer used in the cannula.
The American Hospital Association (AHA) and the Association for Advancement of Medical Instrumentation (AAMI) brought together a small group composed of hospital and health system leaders, device manufacturers and policy leaders to explore how to make devices safer by design.
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
The Food and Drug Administration Feb. 18 announced that ICU Medical is voluntarily recalling certain lots of its potassium chloride injection bags with overwrap labels displaying 10 mEq that are packaged in 20 mEq cases. The FDA said the company learned of the issue from a customer complaint.
The Trump administration yesterday announced it issued executive orders authorizing 25% tariffs on all steel and aluminum imports. Importantly, both steel and aluminum are used broadly for medical devices such as surgical instruments, prosthetics, implants, crutches, wheelchairs, plates and screws…
The Food and Drug Administration Dec. 31 released an alert highlighting a Baxter letter that recommended health care providers not use certain lots of Solution Sets with Duo-Vent Spikes due to a potentially high-risk issue.
Medline Industries initiates recall of Chinese-made plastic syringes in the U.S.
The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes.
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that…