FDA: Class I recall of Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration
Editor's Note The Food and Drug Administration (FDA) on November 30 identified the recall by Synaptive Medical of its BrightMatter Guide with SurfaceTrace Registration, which is used to perform neurosurgical procedures, as Class I, the most serious. The recall was initiated because of a software defect that could potentially result…
FDA: Class I recall of Zimmer Biomet spinal fusion, long bone stimulators
Editor's Note The Food & Drug Administration (FDA) on November 26 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator as Class I, the most serious. The recall was initiated because of the…
FDA: Fresenius Kabi recalls sodium chloride injection
Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…
FDA: Class I recall of Cardiosave Hybrid and Rescue IABPs
Editor's Note The Food & Drug Administration on November 2 identified the recall by Maquet Datascope Corp/Getinge Group’s Cardiosave Hybrid and Cardiosave Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the potential for the autofill process to malfunction or fail during…
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…
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