Aug 24, 2023
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.
Jul 21, 2023
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.
Jul 10, 2023
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.
Jul 7, 2023
The Consumer Financial Protection Bureau, Centers for Medicare…
Jun 6, 2023
As urged by the AHA and its professional membership group the Association for Health Care Resource…
Apr 24, 2023
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…
Apr 6, 2023
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…
Dec 19, 2022
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.
Nov 21, 2022
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…
Nov 3, 2022
The Food and Drug Administration this week alerted health care providers to a shortage of tracheostomy tubes, used to help people breathe after a tracheotomy, including a tube made by ICU Medical for pediatric patients.