Tag: patient_safety

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.

Health Science & Technology Business Politics and Government Medical Science Artificial Intelligence Energy Social Issues Education Penn Nursing Nurse Staffing Pennsylvania Hospitals Patient Safety Healthcare Costs Hospital Management Medical Research
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…

Health Business Medical Science Federal Government Legal Product Recall Medline Namic Manifolds FDA Class I Recall Medical Devices Patient Safety Food Recalls Drugs

Tag: patient_safety

FDA Issues Early Alert for Baxter Volara System Circuits Due to Leakage Risk

Penn Nursing Study Links Nurse Staffing to Patient Outcomes and Cost Savings

FDA Issues Early Alert on Hamilton Medical Breathing Circuit Sets

FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Over Oxygen Delivery Risk

FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

FDA Issues Early Alert on ICU Medical IV Tubing Sets Over Contamination Concerns

FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks