FDA: Class I recall of Stryker Pleural and Pneumopericardial Drainage Sets
Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall of Stryker Fuhrman’s Pleural and Pneumopericardial Drainage Sets as Class I, the most serious. Stryker (Tempe, Arizona) received two reports that the catheter included in the Drainage Set broke off in the patient’s pleural cavity during…
FDA: Hospira recalls one lot of Magnesium Sulfate Injection
Editor's Note The Food and Drug Administration (FDA) announced January 6 that Hospira, Inc (Lake Forest, Illinois) recalled one lot of Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry November 1, 2016). The recall was initiated because of…
FDA strengthens requirements for surgical mesh for transvaginal repair of pelvic organ prolapse
Editor's Note The Food and Drug Administration (FDA) on January 4 issued two final orders to strengthen the requirements for surgical mesh to repair pelvic organ prolapse tranvaginally. One order reclassifies surgical mesh from class II (moderate risk) to a class III (high-risk) device. The second order requires manufacturers to…
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Editor's Note The Food and Drug Administration (FDA), on December 31, 2015, released draft guidance on “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).”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FDA issues draft guidance on UDI convenience kits
Editor's Note The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.”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…
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