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…
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: Downing Labs recalls all sterile products
Editor's Note Downing Labs, LLC (Farmers Branch, Texas) is recalling all lots of compounded and packaged sterile products because of concerns of sterility assurance. The products were distributed between April 20 and September 15, 2015. Posted 10/21/2015] AUDIENCE: Consumer, Pharmacy ISSUE: Downing Labs, LLC is voluntarily recalling all lots…
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 safety alert: Heater-cooler devices linked to infections
Editor's Note The Food and Drug Administration on October 15 issued a safety alert that heater-cooler devices have been associated with Nontuberculous Mycobacteria infections, primarily in patients undergoing cardiothoracic surgical procedures. Devices include: oxygenator heat exchangers cardioplegia heat exchangers warming/cooling blankets. Between January 2010 and August 2015, the FDA received…
FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies
Editor's Note The Food and Drug Administration on October 5 ordered three manufacturers of duodenoscopes marketed in the US to study the reprocessing of their devices in the clinical setting where they are used. The three manufacturers—Olympus America, Inc; Fujifilm Medical Systems, USA, Inc; and Hoya Corp (Pentax Life Care…
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: Cranial perforator automatic clutch mechanism may fail to disengage
Editor's Note The Food and Drug Administration (FDA), on September 28, issued a safety alert for cranial perforators with an automatic clutch mechanism. Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling into the brain. However this clutch mechanism…
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