FDA: Class I recall of RVO 2.0 Raindrop near vision inlay
Editor's Note The Food & Drug Administration (FDA) on March 5 identified the recall by RVO 2.0, Inc (Aliso Viejo, California) of its Raindrop near vision inlay as Class I, the most serious. All lots of the inlay are being recalled because data from the post-approval study showed an increased…
FDA issues Safety Communication on using surgical robots in women’s health
Editor's Note The Food and Drug Administration (FDA) on February 28 issued a Safety Communication on the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer in women. The FDA cited limited, preliminary evidence that the use of robotically-assisted surgical…
FDA: Class I recall of Physio-Control LIFEPAK 15 Monitor/Defibrillator
Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by Physio-Control, Inc (Redmond, Washington) of its LIFEPAK 15 Monitor/Defibrillator as Class I, the most serious. The recall was initiated because the device may “lockup” (freeze) after a shock is delivered. Once it freezes, it cannot…
FDA: Class I recall of ICU Medical’s ChemoLock Vial Spike
Editor's Note The Food & Drug Administration (FDA) on February 22 identified the recall by ICU Medical (San Clemente, California) of its ChemoLock Vial Spike (20 mm) as Class I, the most serious. The recall was initiated because of the potential for plastic particles to break off the protective cap.…
FDA: Class I recall of Smiths Medical Sterile Saline and Water for Inhalation
Editor's Note The Food & Drug Administration (FDA) on February 4 identified the recall by Smiths Medical (Minneapolis, Minnesota) of certain lots of Sterile Saline and Water for Inhalation as Class I, the most serious. The recall was initiated because of potential exposure to infectious agents (bacillus infantis and staphylococcus…
FDA: Class I recall of Medtronic’s Dual Chamber Implantable Pulse Generators
Editor's Note The Food & Drug Administration (FDA) on February 15 identified Medtronic, Inc’s (Dublin, Ireland) recall of it’s Dual Chamber Implantable Pulse Generators (IPGs) as Class I, the most serious. The recall was initiated because of the possibility of a software error that can result in a lack of…
FDA: Class I recall of Edwards Lifesciences Swan-Ganz Thermodilution Catheter
Editor's Note The Food and Drug Administration (FDA) on February 5 identified the recall by Edwards Lifesciences (Irvine, California) of its Swan-Ganz Thermodilution Catheter as Class I, the most serious. The recall was initiated because of incorrect assembly and reversal of catheter lumens that can expose the patient to serious…
FDA warns of link between breast implants and anaplastic large cell lymphoma
Editor's Note The Food and Drug Administration (FDA) on February 6 posted a letter that was sent to healthcare providers to increase their awareness of the association between all breast implants, regardless of filling or texture, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). As of September 30, 2018, the…
FDA: Sun Pharmaceutical recalls four lots of Vecuronium Bromide
Editor's Note The Food & Drug Administration (FDA) on January 8 announced the recall by Sun Pharmaceutical Industries, Inc (Cranbury, New Jersey) of three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder) (Lots: JKS0443A, JKS0444A, JKS0477A), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder)…
FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software
Editor's Note The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious. The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s…
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