FDA Reports

November 12, 2009

Ti Synex II Vertebral Body Replacement Recall

FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in […]
November 9, 2009

CardioVations EndoClamp Aortic Catheter Recall

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks […]
November 4, 2009

Premie Pack and Meconium Pack Recall

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. […]
October 30, 2009

Pointe Scientific Liquid Glucose Hexokinase Reagent Recall

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail […]
October 20, 2009

American Regent Recalls Ketorolac Tromethamine Injection

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials American Regent conducts nationwide voluntary recall of […]
October 6, 2009

Unomedical Recalls Manual Pulmonary Resuscitators (MPRs)

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator […]
October 1, 2009

New USP Standards for Heparin Products

New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be Needed to Achieve Desired Anticoagulant Effect in Some Patients New Heparin to […]
September 28, 2009

Philips Recalls Heartstart Fr2+ External Defibrillators

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of […]
September 17, 2009

Stolen Respiratory Medications in Florida

FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution The U.S. Food and Drug Administration today advised consumers not […]