Medical Device Safety
Baxter Healthcare Corp. recently recalled its Abacus software for ordering compounded liquid medications due to a risk the printed bag labels may contain incorrect information, the FDA announced.
Smiths Medical recently recalled more than 118,000 Medfusion syringe infusion pumps whose software could malfunction, the FDA announced.
CVS Health and Walgreens recently launched clinical trials businesses with an eye toward reducing research costs and making it easier for historically underrepresented racial and ethnic groups to participate in drug and medical device studies.
The FDA released an update on Medtronic’s recall of 1,614 devices used to pump blood from the heart to the rest of the body
The House voted to pass legislation that would reauthorize FDA user fee programs.
Philips Respironics and Adamis Pharmaceuticals announce recalls.
Cordis Corporation recently recalled 25,000 catheters used to visualize and measure parts of the vascular system, due to the potential for their marker bands to move or dislodge during procedures. The Food and Drug Administration has identified this as a Class I recall due to the potential for…
The Food and Drug Administration reported 55 injuries and one death involving an infusion pump and vital signs monitoring system.
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.
In light of closures and potential closures of certain facilities that use gas ethylene oxide (EtO) to sterilize medical devices prior to their distribution and use, the Food and Drug Administration (FDA) is concerned about the future availability of medical devices and possible medical device…