HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date
Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange. (Source: FDA MedWatch)
Source: FDA MedWatch - September 16, 2015 Category: American Health Source Type: news
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program
Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS. (Source: FDA MedWatch)
Source: FDA MedWatch - September 15, 2015 Category: American Health Source Type: news
Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products
FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs. (Source: FDA MedWatch)
Source: FDA MedWatch - September 12, 2015 Category: American Health Source Type: news
Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density
FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels. (Source: FDA MedWatch)
Source: FDA MedWatch - September 10, 2015 Category: American Health Source Type: news
Medistat RX Sterile Drug Products: Recall - Possible Contamination
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. (Source: FDA MedWatch)
Source: FDA MedWatch - September 10, 2015 Category: American Health Source Type: news
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning
An interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately. (Source: FDA MedWatch)
Source: FDA MedWatch - September 8, 2015 Category: American Health Source Type: news
Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed
A patient not receiving enough oxygen can result in possible injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - September 2, 2015 Category: American Health Source Type: news
Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries
If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - September 2, 2015 Category: American Health Source Type: news
DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling. (Source: FDA MedWatch)
Source: FDA MedWatch - August 28, 2015 Category: American Health Source Type: news
OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. (Source: FDA MedWatch)
Source: FDA MedWatch - August 28, 2015 Category: American Health Source Type: news
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
Over or under infusion of fluids to the patient has the potential to cause patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - August 27, 2015 Category: American Health Source Type: news
Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - August 27, 2015 Category: American Health Source Type: news
Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate
The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. (Source: FDA MedWatch)
Source: FDA MedWatch - August 26, 2015 Category: American Health Source Type: news
Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation. (Source: FDA MedWatch)
Source: FDA MedWatch - August 25, 2015 Category: American Health Source Type: news
Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes
Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label. (Source: FDA MedWatch)
Source: FDA MedWatch - August 21, 2015 Category: American Health Source Type: news
