FDA panel recommends reclassification of surgical staplers to Class II
Editor's Note The Food & Drug Administration’s General and Plastic Surgery Devices Advisory Committee on May 30 recommended that surgical staplers be reclassified from Class I to Class II devices. This would add premarket review and special controls to the devices. The Committee said Class II regulation would offer a…
FDA: Class I recall of SOLOPATH Balloon Expandable TransFemoral System, Re-Collapsible Balloon Access System
Editor's Note The Food & Drug Administration on May 30 identified the recall by Terumo Medical Corporation (Somerset, New Jersey) of its SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System as Class I, the most serious. The recall was initiated because the tip could dislodge from the outer…
FDA: Heritage Pharmaceuticals recalls Amikacin Sufate Injection, Prochlorperazine Edisylate Injection
Editor's Note The Food & Drug Administration (FDA) on May 28 announced the recall by Heritage Pharmaceuticals Inc (East Brunswick, New Jersey) of Amikacin Sulfate Injection, USP 1 gm/4 mL (250 mg/mL), Lot: VEAC025, Expiry Date: October 2019; and Prochlorperazine Edisylate Injection, USP 10 mg/2 mL (5 mg/mL), Lot: VPCA172,…
FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems
Editor's Note The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious. The recall was initiated because of…
FDA: Class I recall of Ethicon circular staplers
Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…
FDA issues alert on premature battery depletion in certain Medtronic pacemakers
Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…
FDA: Class I recall of Neuro Omega System
Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…
FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters
Editor's Note The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious. The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or…
FDA issues draft guidance on initiating voluntary recalls
Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls. The guidance includes recommendations in three areas: proper training of personnel thorough and organized record keeping written recall initiation procedures. The guidance…
FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples
Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…
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