Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Penumbra Inc. - Penumbra 3D Revascularization Device - Class 1 Recall
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 23, 2017 Category: Medical Devices Source Type: alerts
Kingsway Trading Inc. Recalls “ Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement ” because it Contains Banned Ephedra Alkaloids
Kingsway Trading Inc. of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “ Well Balance Xanthium& Siler Combo (Bi Yan Pian) ” Batch No. 130401& Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent. (Source: FDA Food Safety)
Source: FDA Food Safety - February 8, 2017 Category: Food Science Source Type: alerts
Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 22, 2016 Category: American Health Source Type: alerts
Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 5, 2016 Category: American Health Source Type: alerts
Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 7, 2016 Category: American Health Source Type: alerts
Super Herbs Capsules: Recall - Undeclared Drug Ingredients
Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 12, 2016 Category: American Health Source Type: alerts
Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical: Recall - Catheter Tip Fracture and/or Separation
Risk of stroke, kidney injury, or damage to the intestines or limbs. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 11, 2016 Category: American Health Source Type: alerts
Concentric Medical Inc - Trevo Pro 4 Stent Retriever - Class 2 Recall
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 9, 2014 Category: Medical Equipment Source Type: alerts
