Product Recalls

Latest Issue of OR Manager
December 2017

FDA: Baxter recalls one lot of injectable amiodarone

Editor's Note The Food and Drug Administration (FDA) on November 15 announced the recall by Baxter International (Deerfield, Illinois) of one lot of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection because of the presence of particulate matter. The particulate matter was identified as polyethylene, the primary constituent of the…

Read More

By: Judy Mathias
November 16, 2017
Share

FDA: Safety Alert for Cardinal Health’s Infant/Child Reduced Energy Defibrillation Electrodes

Editor's Note The Food and Drug Administration (FDA) on November 6 issued a Safety Alert saying that Physio-Control (Redmond, Washington) launched a voluntary field action for specific lots of Infant/Child Reduced Energy Defibrillation Electrodes manufactured by Cardinal Health (Dublin, Ohio). There is an issue with the artwork on the electrodes…

Read More

By: Judy Mathias
November 8, 2017
Share

FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron

Editor's Note The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as…

Read More

By: Judy Mathias
November 7, 2017
Share

FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold

Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…

Read More

By: Judy Mathias
October 31, 2017
Share

FDA: SCA pharmaceuticals recalls certain lots of injectable products

Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products.  The recall was initiated because of the potential for the products to contain microbial contamination.  Many of the recalled products are used in anesthesia,…

Read More

By: Judy Mathias
October 24, 2017
Share

FDA updates Safety Alert for St Jude defibrillators

Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…

Read More

By: Judy Mathias
October 23, 2017
Share

FDA alerts healthcare providers about EVAR graft endoleaks

Editor's Note The Food & Drug Administration (FDA) on September 28 sent letters to vascular and cardiothoracic surgeons, radiologists, and cardiologists, alerting them to an increase in Type III endoleaks associated with endovascular graft systems used in endovascular aneurysm repair (EVAR) for abdominal aortic and aorto-iliac aneurysms. The FDA’s letter…

Read More

By: Judy Mathias
September 28, 2017
Share

FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter

Editor's Note The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious. The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control…

Read More

By: Judy Mathias
September 26, 2017
Share

FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific

Editor's Note The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific. After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on…

Read More

By: Judy Mathias
September 19, 2017
Share

FDA: OriGen recalls two lots of dual lumen ECMO catheters

Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…

Read More

By: Judy Mathias
September 14, 2017
Share
Hot Products
Product Spotlight: Halyard Health AERO SERIES*

With AERO SERIES* Gowns, less equals more Reduce your surgical gowns codes by 40% while you increase

Live chat by BoldChat