MedWatch Safety Alerts

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

UPDATED 08/27/2014. Lot numbers added.

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

Potential adhesion defect which may lead to infection.

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

Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.

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

Fragments of the sheath could possibly block blood vessels.

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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

Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

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

Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.

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Arize: Public Notification - Undeclared Drug Ingredient

Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

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