Recall Class: Class I Date Recall Initiated: August 4, 2010 Product(s): All Colleague Single Channel Infusion Pumps All Colleague Triple Channel Infusion Pumps Use: Colleague Single and Triple Channel infusion pumps are medical devices that deliver intravenous fluids and medicine to patients in hospitals, outpatient surgical centers, hospices, nursing homes, and in ambulances. They are…
Class I Medical Device Recall: B. Braun addEASE Binary Connector
Recall Class: Class I Date Recall Initiated: June 24, 2010 Product: addEASE Binary Connectors Catalog numbers N7990 and N7933 Manufactured and distributed from April 4, 2004 to June 4, 2010 Use: The addEASE is used to transfer fluid between a partial additive bag (PAB) and a drug vial. Recalling Firm: B. Braun Reason for Recall:…
Class I Medical Device Recall: WalkMed, Inc. Triton Pole Mount Infusion Pump
Recall Class: Class I Date Recall Initiated: June 16, 2010 Product: Triton Pole Mount Infusion Pump The recall includes the serial numbers 001 through 500 and serial numbers TR1401 through TR 2559 manufactured and sold before June 2010. Use: Indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA…
Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/2010
Original Date Issued: August 26, 2010 Date Updated: November 29, 2010 Audience: All healthcare personnel who perform blood sampling, including point of care nurses, physicians, laboratory personnel and phlebotomists, as well as patients whose blood is routinely sampled. Medical Specialties: All medical specialties, particularly Internal Medicine, Emergency Medicine, Family Practice, Endocrinology, Pediatrics, Intensive Care, Obstetrics/Gynecology…
Guidance for Industry and Food and Drug Administration Staff
Document issued on: November 29, 2010 For questions regarding this document contact Sheila A. Murphey, MD, 301-796-6302, [email protected] or Neil Ogden, 301-796-6397, [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of Device EvaluationDivision of Surgery, Orthopedic and Restorative Devices Preface Public Comment You may submit written comments and…
Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.Document issued on: November 29, 2010 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food…
Class I Medical Device Recall: Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes ? Sealed in Pouches
Recall Class: I Date Recall Initiated: March 15, 2010 Products: Surgical Sealant Dispensers  Micromedics Nasal Septal Buttons Otological Ventilation Tubes These products were manufactured from February 9, 2010 through March 4, 2010 and distributed from February 15, 2010 through March 4, 2010. Use: Surgical Sealant Dispenser – Instrument for the application of two liquids…
Consumer Information on: Boston Scientific Cardiac Resynchronization Therapy Defibrillators
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: LIVIAN®, COGNIS® and CONTAK RENEWAL®…
FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References Safety Announcement [11-19-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has…
Needleless Pre-filled Glass Syringes: Stakeholder Advisory
Reports Received on Adenosine and Amiodarone Products  [Posted 11/17/2010] AUDIENCE: Critical Care Medicine, Emergency Medicine, Cardiology, Risk Manager ISSUE: FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes…