Boston Scientific Implantable Cardioverter Defibrillators: Recall
Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer.
Continue reading...
19. March 2010
Posted in: FDA Alerts and Warnings
Zocor (simvastatin): increased risk of muscle injury with high doses
Ongoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs.
Continue reading...
18. March 2010
Posted in: FDA Alerts and Warnings
Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall
Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream.
Continue reading...
16. March 2010
Posted in: FDA Alerts and Warnings
Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall
Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized.
Continue reading...
16. March 2010
Posted in: FDA Alerts and Warnings
Cleviprex (clevidipine butyrate): Recall
The recall of 12/2009 has been expanded to include four additional lots. Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.
Continue reading...
16. March 2010
Posted in: FDA Alerts and Warnings
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall
Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
Continue reading...
12. March 2010
Posted in: FDA Alerts and Warnings
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.
Continue reading...
12. March 2010
Posted in: FDA Alerts and Warnings
Counterfeit Polypropylene Surgical Mesh: Initial Communication
Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.
Continue reading...
11. March 2010
Posted in: FDA Alerts and Warnings
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Continue reading...
11. March 2010
Posted in: FDA Alerts and Warnings
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
Continue reading...
19. March 2010
Posted in: FDA Alerts and Warnings