| 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. |
12-Mar-2010 |
| 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. |
11-Mar-2010 |
| 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. |
11-Mar-2010 |
| Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall |
Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell. |
11-Mar-2010 |
| Abiomed AB5000 Circulatory Support System: Class I Recall |
Device computer may shut down without an alarm, which can lead to serious injuries or death. |
10-Mar-2010 |
| WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis |
Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho. |
10-Mar-2010 |
| 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 |
8-Mar-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. |
5-Mar-2010 |
| 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. |
3-Mar-2010 |
| 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. |
26-Feb-2010 |