From the category archives:

MedWatch

DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall – May Reverse Directions After Surgery

August 28, 2014

Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take [...]

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Sterile Convenience Surgical Packs by Customed, Inc.: Recall – Potential Loss of Sterility

August 26, 2014

Potential adhesion defect which may lead to infection. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall – Possibility of Mold

August 22, 2014

Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice [...]

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CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall – Risk of Loop to Separate From Shaft

August 20, 2014

Use of affected product may result in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the [...]

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Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall – Sheath May Fracture During Use

August 19, 2014

Fragments of the sheath could possibly block blood vessels. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall – Presence of Particulate Matter

August 15, 2014

Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details [...]

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IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall – Microbial Contamination

August 12, 2014

Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Arize: Public Notification – Undeclared Drug Ingredient

August 11, 2014

Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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Herbal Vigor Quick Fix: Public Notification – Undeclared Drug Ingredient

August 11, 2014

Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall – Foreign Particulate Matter

August 8, 2014

Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original [...]

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