FDA: Class I recall of CyPass Micro-Stent Systems
Editor's Note The Food & Drug Administration (FDA) on October 24 classified Alcon Research’s recall of its CyPass Micro-Stent Systems as Class I, the most serious. The recall was initiated because of the risk of corneal endothelial cell loss with the system, which is used in conjunction with cataract surgery…
FDA: Safety Communication on Raindrop Near Vision Inlay
Editor's Note The Food & Drug Administration (FDA) on October 23 issued a Safety Communication on the increased risk of corneal haze associated with the Raindrop Near Vision Inlay, which is surgically implanted in the cornea of one eye to improve near vision. The notice is to alert eye care…
FDA: Promise Pharmacy recalls one lot of Prednisolone, Gatifloxacin Ophthalmic Solution
Editor's Note The Food & Drug Administration (FDA) on October 22 announced the recall by Promise Pharmacy (Palm Harbor, Florida) of one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3 mL vials (Lot Number 09042018@2, Exp 12/03/2018). The recall was issued because the product was found to have…
FDA: Class I recall of Endologix AFX Endovascular AAA System
Editor's Note The Food & Drug Administration on October 15 classified the recall by Endologix, Inc, of its AFX Endovascular AAA System as Class I, the most serious. The recall was initiated because of the risk of Type III endoleaks. When a Type III endoleak occurs, blood continues to flow…
FDA: Endo Pharmaceuticals recalls two lots of Robaxin
Editor's Note The Food & Drug Administration on September 28 announced the recall by Endo Pharmaceuticals Inc of two lots of Robaxin 750 mg tablets because of incorrect dosing information on the label. Robaxin contains methocarbamol, which is used as a muscle relaxant. Patients who follow the incorrect dosing information…
FDA: Oscor Inc recalls TB-Temporary Bipolar Pacing Leads
Editor's Note The Food and Drug Administration (FDA) on September 27 announced the recall by Oscor Inc (Palm Harbor, Florida) of its TB-Temporary Bipolar Pacing Leads, with 2 mm unshrouded connectors. The recall was initiated because the connector cap housing may slide and expose the connection wire. This may cause…
FDA: Getinge recalls Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump
Editor's Note The Food and Drug Administration (FDA) on September 30 posted an announcement by Getinge that it is voluntarily initiating a worldwide recall involving a field correction of some 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp. The recall is because of the potential for interruption…
FDA: Pharm D Solutions recalls all sterile compounded drugs
Editor's Note The Food and Drug Administration (FDA) on September 10 posted the announcement by Pharm D Solutions, LLC, (Houston, Texas) that it had voluntarily issued a recall of all sterile compounded drugs because of a potential lack of sterility. The company says concerns about practices at the pharmacy that…
FDA: Class I recall of Arkon Anesthesia Delivery System
Editor's Note The Food & Drug Administration on August 10 identified the recall of Spacelabs Healthcare’s (Snoqualmie, Washington) Arkon Anesthesia Delivery System as Class I, the most serious. The recall was issued because of the system going into a “failed state,” during which the mechanical ventilation function stops working. This…
FDA issues update on wearable cardioverter defibrillator
Editor's Note The Food and Drug Administration (FDA) on July 25 issued an update for the Zoll LifeVest 4000 wearable cardioverter defibrillator. The update provides information on efforts by Zoll to remedy the potential hazard of the device failing to deliver a life-saving shock if not replaced soon after displaying…
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