Search Results
The default setting for search results displays All Content. If you prefer to see recent content only, please adjust the date filter.
Filter your results:
Types
Topics
38 Results Found
FDA evaluating certain plastic syringes made in China
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 medical devices, such as infusion pumps.
FDA announces Class I ventilator recall for Draeger product’s pediatric use
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.
Pfizer issues update on sterile injectables plant struck by tornado
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.
Agencies target unapproved pharmaceutical products from India
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.
Agencies seek information on medical payment products
The Consumer Financial Protection Bureau, Centers for Medicare & Medicaid Services, Department of Health and Human Services, and Department of the Treasury jointly released a Request for Information regarding certain medical payment products, including medical credit cards, loans and other financial products used to pay for health care.
FDA releases guidance to help hospitals conserve pneumatic tourniquet cuffs
As urged by the AHA and its professional membership group the Association for Health Care Resource & Materials Management, the Food and Drug Administration yesterday released guidance to help hospitals and other health care providers conserve pneumatic tourniquet cuffs after a recent recall led to local supply shortages.
FDA updates use recommendations for Halyard surgical N95 respirator
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&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask for fluid barrier protection if they wear a face shield over the respirator.
FDA withdraws approval for premature birth drug
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 a history of spontaneous preterm birth.
FDA issues Class I recall of venous access, catheter kits
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.
FDA reports issues with certain reworked Philips ventilators
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 backing, potentially blocking the air inlet and lowering inspiratory pressure, FDA said.