Recalls for 04/27/2020

UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers
04/27/2020 Medical Recall

FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.

UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers
04/27/2020 Medical Recall

The FDA is issuing this update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons
04/27/2020 Medical Recall

The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. The first type of adverse event involves balloon over-inflating and the second type is development of acute pancreatitis.

Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers
04/27/2020 Medical Recall

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to health care organization during the Coronavirus Disease 2019 (COVID-19) outbreak.

UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers
04/27/2020 Medical Recall

An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)
04/27/2020 Medical Recall

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi