FDA: Baxter recalls two lots of IV solutions
Editor's Note The Food and Drug Administration on January 5 announced that Baxter International, Inc (Deerfield, Illinois) is recalling two lots of IV solutions because of the presence of particulate matter. The particulate matter was determined to be an insect and was identified as a result of a customer complaint.…
FDA proposes early warning system for medical devices
Editor's Note The Food and Drug Administration (FDA), on December 31, 2015, released draft guidance on “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The draft proposes a policy for how the FDA will notify the public about “emerging signals” (ie, new information) of possible device risks before…
FDA issues draft guidance on UDI convenience kits
Editor's Note The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.” The document outlines the FDA’s interpretation that the term “convenience kit,” as defined by 21 CFR 801.3, applies solely to…
FDA: Class I recall of Perseus A500 Anesthesia Workstation
Editor's Note The Food and Drug Administration, on December 23, 2015, classified the recall of the Perseus A500 Anesthesia Workstation by Draeger as Class I, the most serious. Draeger Medical (Telford, Pennsylvania) recalled the workstation because a faulty power switch may fail, causing the workstation to alarm and shut down…
FDA: Boston Scientific recalls Chariot Guiding Sheath
Editor's Note The Food and Drug Administration on December 11 announced that Boston Scientific (Marlborough, Massachusetts) recalled its Chariot Guiding Sheath because of the risk of shaft separation. The company received 14 complaints of shaft separation, four of which involved separation of the distal shaft. The Sheath is used to…
FDA: Class I recall of Inspiration LS, 5i, and 7i ventilators
Editor's Note The Food and Drug Administration on December 7 categorized the recall of Inspirtion LS, 5i, and 7i ventilator systems manufactured before January 21, 2015, by eVent Medical (Lake Forest, California) as Class I, the most serious. The recall was initiated because a faulty switch on the ventilators’ power…
FDA: Boston Scientific recalls RotaWire Elite and wireClip Torquer Guidewires
Editor's Note Boston Scientific Corporation is recalling RotaWire Elite core wires because they may crack and separate from the rest of the Rotablator Rotational Atherectomy System and cause serious injury such as tamponade, myocardial infarction, and migration of wire fragments, the Food and Drug Administration reported November 27. Boston Scientific…
FDA: Class I recall of G5 Ventilators by Hamilton
Editor's Note The Food and Drug Administration on November 13 identified the recall of Hamilton G5 Ventilators V2.00 and V2.31 as Class I, the most serious. The ventilator may stop working, without sounding an alarm, when the oxygen enrichment key is pressed to attach the mask to the patient. If…
FDA orders recall of all Custom Ultrasonics automated endoscope reprocessors
Editor's Note The Food and Drug Administration (FDA) on November 13 ordered Custom Ultrasonics (Ivyland, Pennsylvania) to recall all of its automated endoscope reprocessors from healthcare facilities because of federal law violations and a consent decree entered with the company in 2007. The violations could result in an increased risk…
GAO issues report on FDA postmarket studies on medical devices
Editor's Note More than half (56%) of 313 medical device postapproval studies ordered by the Food and Drug Administration (FDA) from January 1, 2007, through February 23, 2015, were for cardiovascular devices, and most are making adequate progress, according to a Government Accountability Office (GAO) report. Postapproval studies are ordered…
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