Archive for March, 2010
Zocor (simvastatin): increased risk of muscle injury with high doses
Zocor: Ongoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs.
Boston Scientific Implantable Cardioverter Defibrillators: Recall
Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer.
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.
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.
Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall
Device implanted for ventilation or drainage of the middle ear – shipped without being sterilized.
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: 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.
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
StatSpin Express 4 Centrifuges Model 510: Recall
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
OneTouch SureStep Test Strips (LifeScan): Recall
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Invirase (saquinavir): Ongoing safety review of clinical trial data
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
