The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits (scrubs), may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak. The following conservation strategies for use by health care organizations and…
Fresenius Kabi’s Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)
Summary Company Announcement Date: April 23, 2020 FDA Publish Date: April 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description presence of particulate matter Company Name: QuVa Pharma, Inc. Brand Name: Brand Name(s) Product Description: Product Description R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe Company Announcement SUGAR…
Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Vascular Solutions, Inc. Langston Dual Lumen Catheter Lot Numbers: Lots distributed between July 12, 2019 and March 10, 2020 Model Number: Model 6F 5540 Manufacturing Dates: June…
CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets
Summary Company Announcement Date: April 27, 2020 FDA Publish Date: April 29, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids Company Name: CME America Brand Name: Brand Name(s) CMEAmerica BodyGuard Product Description:…
The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons
February 9, 2017 Dear Health Care Provider, The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications…
UPDATE: Potential Risks with Liquid-filled Intragastric Balloons – Letter to Health Care Providers
April 27, 2020 – UPDATE: Potential Risks with Liquid-filled Intragastric Balloons – Letter to Health Care Providers December 9, 2019 LHCP UPDATE: As of January 1, 2019, Apollo Endosurgery stopped selling and distributing the ReShape Balloon (which was acquired by Apollo Endosurgery in December 2018). Because the ReShape Balloon is no longer available, the post-approval study…
Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication – FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems
[Posted 04/24/2020] AUDIENCE: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional ISSUE: FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or…
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers
Summary Company Announcement Date: April 17, 2020 FDA Publish Date: April 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-Specification Results for High Molecular Weight Polymers Company Name: Braun Medical Inc Brand Name: Brand Name(s) Product Description: Product Description Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in…
Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753
Summary Company Announcement Date: April 20, 2020 FDA Publish Date: April 21, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Incorrect factory-set unit of measure Company Name: Trividia Health, Inc. Brand Name: Brand Name(s) TRUE METRIX Product Description: Product Description TRUE METRIX® AIR Blood Glucose Meter Company Announcement Trividia Health, Inc. today…
Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples
Summary Company Announcement Date: April 20, 2020 FDA Publish Date: April 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Particulate Matter Company Name: Fresenius Kabi USA, LLC Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2…