Tag: patient_safety

FDA Issues Early Alert on Baxter Duo-Vent Solution Sets Over Air Bubble Risk

20 Jul 2026 12:42 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Baxter Duo-Vent solution sets, which may introduce air bubbles into IV lines, posing serious risks like stroke or death for vulnerable patients. Baxter recommends removal of affected lots.

Health Business Politics and Government Medical Science Federal Government Social Issues Baxter Duo-Vent solution sets Air bubbles Medical devices FDA Product Recall Patient safety Food Recalls Drugs
FDA Issues Early Alert for Resmed Ventilators Over Leakage Risk

15 Jul 2026 6:33 p.m. · Source: US Food and Drug Administration

The FDA issued an Early Alert for Resmed Astral 100 and 150 ventilators due to supercapacitor leakage, potentially causing therapy discontinuation. Five serious injuries are reported. Patients should not stop using devices without clinician instruction, as this issue could lead…

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Memphis Gynecologist Sentenced to 20 Years for Medical Device Adulteration and Healthcare Fraud

14 Jul 2026 10:33 a.m. · Source: FBI

Sanjeev Kumar, a Memphis gynecologist, received a 20-year prison sentence for adulterating medical devices and healthcare fraud. He performed over 15,000 procedures with unsafe devices on Medicare and Medicaid patients, netting millions.

Health Law Enforcement Politics and Government Medical Science Legal Federal Government Social Issues Sanjeev Kumar Memphis Gynecologist Healthcare Fraud Medical Devices Adulteration Patient Safety FBI
FDA Issues Early Alert for Baxter Volara System Circuits Due to Leakage Risk

11 Jun 2026 1:15 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert regarding Baxter's Volara System single-patient use circuits, which may leak air and medication. This issue can lead to ineffective therapy and patient desaturation.

Health Business Science & Technology Medical Science Legal Social Issues Baxter Volara System FDA Medical Device Correction Air Leakage Patient Safety Medical Devices Food Recalls Drugs
Penn Nursing Study Links Nurse Staffing to Patient Outcomes and Cost Savings

9 Jun 2026 2:22 a.m.

A Penn Nursing study highlights that increased nurse workloads in Pennsylvania hospitals lead to higher patient deaths, readmissions, and staff turnover. The research suggests that hiring more nurses could be cost-effective by reducing hospital stays and improving retention.

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FDA Issues Early Alert on Hamilton Medical Breathing Circuit Sets

8 Jun 2026 12:47 p.m. · Source: US Food and Drug Administration

FDA issues an Early Alert regarding Hamilton Medical coaxial breathing circuit sets. Certain lots may not perform as intended, leading to impaired exhalation and four reported serious injuries.

Health Business Science & Technology USA Medical Science Federal Government FDA Hamilton Medical Breathing Circuit Sets Medical Devices Early Alert Respiratory Compromise Patient Safety Food Recalls Drugs
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Over Oxygen Delivery Risk

5 Jun 2026 2:50 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for GE HealthCare Infant Resuscitation Systems due to loose blender knob shafts. This defect could cause incorrect oxygen delivery, posing risks of hypoxia or hyperoxia to infants, though no serious injuries are reported.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues GE HealthCare Infant Resuscitation Systems FDA Medical Devices Oxygen Concentration Product Recall Patient Safety Food Recalls Drugs
FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

2 Jun 2026 6:13 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Abiomed's 14Fr Low Profile Introducer Kits due to a high rate of complaints regarding thrombus formation. This issue has led to three serious injuries, prompting Abiomed to recommend removal of all affected…

Health Business Science & Technology Medical Science Federal Government Legal Abiomed FDA 14Fr Low Profile Introducer Kit Thrombus Formation Medical Device Product Recall Patient Safety Food Recalls Drugs
FDA Issues Early Alert on ICU Medical IV Tubing Sets Over Contamination Concerns

27 May 2026 3:59 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert concerning ICU Medical IV tubing sets due to reports of black specks and particulate matter in drip chambers. ICU Medical is investigating potential contamination and patient risk, though no serious injuries have been…

Health Business Politics and Government Medical Science Federal Government Legal Social Issues ICU Medical FDA IV tubing sets Medical devices Product Alert Contamination Patient safety Food Recalls Drugs
FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks

26 May 2026 1:56 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Medline Namic Manifolds and related kits due to particulate in the fluid path. This poses a serious risk of injury or death if introduced into blood circulation, prompting immediate removal of…

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