Product Recalls

Latest Issue of OR Manager
February 2018

FDA issues Safety Alert for Zoll LifeVest 4000 Wearable Cardioverter Defibrillator

Editor's Note The Food & Drug Administration (FDA) on January 17 issued a Safety Alert for the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator because of concerns that the device may fail to deliver treatment to patients if the device is not replaced soon after displaying “Call for service: Device has…

Read More

By: Judy Mathias
January 17, 2018
Share

FDA updates Safety Alert for Cortrak 2 Enteral Access System

Editor's Note The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois). Several of the events were associated with cardiopulmonary arrest, and there were…

Read More

By: Judy Mathias
January 17, 2018
Share

FDA: Class I recall of Certitude Delivery System

Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall by Edwards LifeSciences (Irvine, California) of its Certitude Delivery System as Class I, the most serious. The system is used for delivery of the Edwards SAPIEN 3 transcatheter aortic heart valve. The recall was issued because…

Read More

By: Judy Mathias
January 12, 2018
Share

FDA: PharMEDium recalls 55 lots of compounded sterile drugs

Editor's Note The Food and Drug Administration on January 2 announced the recall by PharMEDium Services (Lake Forest, Illinois) of 55 lots (impacting 25,327 units) of compounded sterile drug products because of a lack of sterility assurance. The recalled products were manufactured in PharMEDium’s Memphis location and distributed nationwide to…

Read More

By: Judy Mathias
January 5, 2018
Share

FDA: AuroMedics recalls Ampicillin and Sulbactam for Injection

Editor's Note The Food and Drug Administration (FDA) on January 4 announced the recall by AuroMedics Pharma LLC (Windsor, New Jersey) of one lot of Ampicillin and Sulbactam for Injection USP 1.5 g in a single-dose vial. The recall was issued because the lot (Lot AFOI 17001-A, Expiry date December…

Read More

By: Judy Mathias
January 4, 2018
Share

FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath

Editor's Note The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious. The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper…

Read More

By: Judy Mathias
January 3, 2018
Share

FDA: Recall of Pharmacist Choice Alcohol Prep Pads

  Editor's Note The Food and Drug Administration (FDA) on December 5 announced the recall of 3 lots of Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics (Coral Springs, Florida), which were manufactured by Foshan Flying Medical Products Co Ltd, located in China. The alcohol pads were recalled because of…

Read More

By: Judy Mathias
December 6, 2017
Share

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
Upcoming Webinars
Live chat by BoldChat