From the category archives:

MedWatch

Potassium Chloride Injection (Baxter): Recall – Shipping Carton Mislabeling

September 17, 2014

Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. 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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Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall – Particulate Matter

September 12, 2014

Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. 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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Pharmacy Creations Certain Products: Recall – Potential Non-Sterility

September 5, 2014

Compromised sterility of a product may lead to risk for 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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Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall – Lack of Assurance of Sterility

September 2, 2014

Compromised sterility of a compounded preparation may lead to risk for 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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Dermatend Original and Dermatend Ultra: Recall – Safety Concerns

September 2, 2014

Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer. 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 [...]

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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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