Products
The Food and Drug Administration is evaluating Chinese-made plastic syringes used to inject or withdraw fluids from the body, citing concern that they may not provide adequate quality and performance, including their ability to deliver the correct dose of medication when used alone or with other…
Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath, which exceed acceptable levels if used by pediatric patients for more than 30 days.
Crews are working to restore power and assess damage to a Pfizer plant in North Carolina that makes sterile injectables for U.S. hospitals after a tornado struck the facility July 19, the company said July 21.
Federal agencies last month stopped over 500 unapproved pharmaceutical products and medical devices, including opioid and other controlled substances, from entering the U.S. from India, the Food and Drug Administration reported Friday.
The Consumer Financial Protection Bureau, Centers for Medicare…
As urged by the AHA and its professional membership group the Association for Health Care Resource…
In response to questions from AHA and others and informed by testing results, the Food and Drug Administration April 21 announced that health care providers without alternative options may continue to use a certain version of the O…
The Food and Drug Administration today withdrew approval for Makena and its generics, citing a confirmatory study that did not verify clinical benefit. Makena had been approved under the FDA’s accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have…
The U.S. Food & Drug Administration has issued a Class I recall, the most serious type of recall, for the Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter Kits.
Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic…