News and Updates
Update: Reduce the Risk for Medical Device Misconnections
Today, the U.S. Food and Drug Administration (FDA) added a new case study to its “Examples of Medical Device Misconnections” webpage. The webpage describes device misconnections based on reports of
Class 1 Recall Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs
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. Device Use CADD ambulatory
Outbreak of Extensively Drug-resistant Pseudomonas Aeruginosa Associated with Artificial Tears
The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and
Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect
Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters are implanted and used in hemodialysis (treatment to filter waste and water from the blood), apheresis (a technology that separates
Prolia (denosumab) by Amgen: Investigating Risk of Severe Hypocalcemia in Patients on Dialysis
The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated
Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage
Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level. The product poses
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