Update: Reduce the Risk for Medical Device Misconnections

February 24th, 2023|

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 adverse events received by the FDA and includes tips to reduce these types of events from occurring. The new case study involves an air inflation

Outbreak of Extensively Drug-resistant Pseudomonas Aeruginosa Associated with Artificial Tears

February 2nd, 2023|

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 Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states. Most patients reported using artificial tears. Patients reported more than 10 different brands of artificial

Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect

January 31st, 2023|

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 donated blood components to treat certain illnesses), and infusion (a method of putting fluids into the bloodstream) for up to 21 days. Medtronic is recalling

Prolia (denosumab) by Amgen: Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

November 29th, 2022|

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 with the osteoporosis medicine Prolia (denosumab). FDA's review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or

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

October 14th, 2022|

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 a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of

Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue

August 30th, 2022|

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain