FDA: Class I recall of Brainlab’s Cranial Image-Guided Surgery System
Editor's Note The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious. The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could…
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: 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: 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: Quest Medical recalls certain lots of Myocardial Protection System delivery sets
Editor's Note Quest Medical, Inc (Allen, Texas), on October 28 initiated a nationwide recall of its Myocardial Protection System delivery sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The sets have shown possible seal failure along the blood source channel of the main pump cassette, resulting in blood loss…
FDA launches new features for UDI database
Editor's Note The Food and Drug Administration (FDA) in partnership with the National Library of Medicine on October 19 announced the launch of three new features on AccessGUDID, the public portal to data submitted to the FDA’s Global Unique Device Identification Database (GUDID). Two new APIs (application program interface) and…
FDA: Class I recall of PROFEMUR modular neck prostheses
Editor's Note The Food and Drug Administration on October 2 categorized the recall of PROFEMUR Neck Varus/Valgus CoCr 8 degree, Part number PHAC 1254, by MicroPort Orthopedics as Class I, the most serious. The company has received reports of unexpected fractures after surgery related to this modular neck. If the…
FDA labels recall of Medtronic’s heart valve loading system Class I
Editor's Note The Food and Drug Administration on August 5 categorized the recall of 6,912 units of Medtronic Cardiovascular Surgery’s EnVeo R loading system as Class I, the most serious. The loading system is used with the CoreValve Evolut R replacement heart valve. The recall was issued over concerns about…
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