All Entries in the "Medical Products" Category
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall
AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack.
Proton Pump Inhibitors (PPI): Class Labeling Change
Possible increased risk of fractures of the hip, wrist, and spine.
Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
Study terminated following the identification of an imbalance of thrombosis of the portal venous system in patients treated with eltrombopag versus matching placebo.
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall
Flex tube may not fit securely within the endotracheal tube (ET) connector.
GE Healthcare Aisys and Avance Anesthesia Systems: Recall
Defective control board wiring harnesses can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Baxter Colleague Infusion Pumps: FDA Ordering Recall
Action based on failure to correct serious problems with infusion pumps.
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.
