All Entries in the "Medical Products" Category
Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall
UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010
LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.
Class I Recall issued because of the potential for the device to expectedly power off and/or power on.
Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes
Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly.
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.
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.
