Drug & Medical Device Recalls & Safety Alerts

Hospira Propofol Injectable Emulsion: Recall – Glass Vial Defect

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Hospira Propofol Injectable Emulsion: Recall – Glass Vial Defect. According to the Food & Drug Administration FDA’s MedWatch: Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss [...]

St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure. According to the Food & Drug Administration FDA’s MedWatch: ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could [...]

Stryker Wingspan Stent System: Safety Communication – Narrowed Indications for Use

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Stryker Wingspan Stent System: Safety Communication – Narrowed Indications for Use. According to the Food & Drug Administration FDA’s MedWatch: Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan. For more information [...]

Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall – System Errors May Cause Device Shutdown

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall – System Errors May Cause Device Shutdown. According to the Food & Drug Administration FDA’s MedWatch: Delay or interruption of infusion therapy could result in serious injury and/or death. For more information [...]

Respironics, Inc., Trilogy 100, 200, and 202 Ventilators: Class I Recall – Power Supply May Fail

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Respironics, Inc., Trilogy 100, 200, and 202 Ventilators: Class I Recall – Power Supply May Fail. According to the Food & Drug Administration FDA’s MedWatch: Ventilator power supply failure may lead to unexpected cessation of ventilation and failure of alarm to sound. For [...]

B. Braun Infusomat Space Infusion System: Class I Recall – Potential for Breakage of Anti Free Flow Clip Catch

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: B. Braun Infusomat Space Infusion System: Class I Recall – Potential for Breakage of Anti Free Flow Clip Catch. According to the Food & Drug Administration FDA’s MedWatch: Misloading of the anti free flow clip catch may create the potential for free flow [...]

CareFusion Alaris PC Unit, Model 8015: Class I Recall – Error Code

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: CareFusion Alaris PC Unit, Model 8015: Class I Recall – Error Code. According to the Food & Drug Administration FDA’s MedWatch: Potential error code may cause a delay in patient therapy or result in serious injury and/or death to the patient. For more [...]

Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient. According to the Food & Drug Administration FDA’s MedWatch: If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa [...]

X-ROCK 3 Day Pill For Men and Z-ROCK: Recall – Undeclared Drug Ingredient

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: X-ROCK 3 Day Pill For Men and Z-ROCK: Recall – Undeclared Drug Ingredient. According to the Food & Drug Administration FDA’s MedWatch: Undeclared active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous [...]

Ampyra (dalfampridine): Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Ampyra (dalfampridine): Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients. According to the Food & Drug Administration FDA’s MedWatch: Patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk. For more information on the [...]

CareFusion EnVe Ventilators: Class I Recall – Leak In Patient Breathing Circuit or System

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: CareFusion EnVe Ventilators: Class I Recall – Leak In Patient Breathing Circuit or System. According to the Food & Drug Administration FDA’s MedWatch: Compromised ventilation delivery to patient may cause serious adverse health consequences, including death. For more information on the drug or [...]

Hospira Injectable Drug Products: Recall – Visible Particulates from Defective Glass Vials

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Hospira Injectable Drug Products: Recall – Visible Particulates from Defective Glass Vials. According to the Food & Drug Administration FDA’s MedWatch: Symptoms of particulate matter injected into a patient might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms. For more [...]

Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall – Potential for Significantly Decreased Precision

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall – Potential for Significantly Decreased Precision. According to the Food & Drug Administration FDA’s MedWatch: Reports of patients receiving inappropriate clinical management which may have been due to erroneous test results. For more information [...]

Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall – Device Field Correction

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall – Device Field Correction. According to the Food & Drug Administration FDA’s MedWatch: Use of this product may cause serious adverse health consequences, including death. For more information on the drug or medical [...]