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Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement – Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608253.htm

 
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SAM XT Extremity Tourniquet Tactical Black (PN SAM XT-M), SAM XT Extremity Tourniquet Hi-Viz Orange (PN SAM XT-C) and SAM XT Extremity Tourniquet Hi-Viz Blue (PN SAM XT-B) (2018-05-01)

SAM XT Extremity Tourniquet Tactical Black (PN SAM XT-M), SAM XT Extremity Tourniquet Hi-Viz Orange (PN SAM XT-C) and SAM XT Extremity Tourniquet Hi-Viz Blue (PN SAM XT-B) (2018-05-01)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66808r-eng.php

 
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7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall – Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered tainted. To date, Shoreside Enterprises, Inc. has not received any reports of adverse events related to this recall.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608142.htm

 
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MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall – Due to Wire Material That May Break or Separate During Use

There is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient’s bloodstream, and this or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608162.htm