Medical Device Safety
The FDA announced a Class 1 recall of devices used to access blood vessels through a patient’s bone because the devices may malfunction, and recommended customers quarantine the devices.
The Environmental Protection Agency released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby.
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.