Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative

FDA has extended the transition period to period to August 2, 2012, with the following requirements: United States Customers currently using the STERIS System 1 (SS1) may continue to receive System 1 sterilant and other support after February 2, 2012, only if those Customers have placed orders for products to replace all remaining SS1’s in…

Eclectic Institute Dietary Supplements: Recall

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Liquid Acetaminophen marketed for infants: Drug Safety Communication

[Posted 12/22/2011] AUDIENCE: Pediatrics, Consumers, Pharmacy ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.  This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using…

ShoulderFlex Massager: Warning

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FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted…

Class I Medical Device Recall: St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads

Recall Class: Class I Date Recall Initiated: November 28, 2011 Product(s): Riata and Riata ST Silicone Endocardial Defibrillation Leads Model/catalog/lot numbers:Riata (8F) Silicone Endocardial Defibrillation LeadsModels: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Riata ST (7Fr) Silicone Endocardial Defibrillation Leads Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Distribution…

Guidance for Industry and Food and Drug Administration Staff

Document issued on: December 20, 2011 The draft of this document was issued on July 12, 2011. For questions regarding this document, contact Scott McFarland at 301-796-6217, or via email at [email protected]@fda.hhs.gov. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Preface You should submit comments and suggestions regarding…

Gilenya (fingolimod): Drug Safety Communication

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