MedWatch Safety Alerts
Potential adhesion defect which may lead to infection.
Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.
CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft
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.
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.
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.
Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.
Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.