OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst
Reports of internal flash fire when the OxyTOTE is mishandled or dropped. (Source: FDA MedWatch)
Source: FDA MedWatch - August 18, 2015 Category: American Health Source Type: news
Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns
Parenteral administration of non-sterile injection products may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome. (Source: FDA MedWatch)
Source: FDA MedWatch - August 18, 2015 Category: American Health Source Type: news
Compounded or Repackaged Drugs Stored in Becton-Dickinson (BD) 3 mL and 5 mL Syringes: FDA Alert - Do Not Use Unless There Is No Suitable Alternative
Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe. (Source: FDA MedWatch)
Source: FDA MedWatch - August 18, 2015 Category: American Health Source Type: news
Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use
Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe. (Source: FDA MedWatch)
Source: FDA MedWatch - August 18, 2015 Category: American Health Source Type: news
Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems
Patients should consider having their mammograms re-evaluated at a certified facility. (Source: FDA MedWatch)
Source: FDA MedWatch - August 17, 2015 Category: American Health Source Type: news
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. (Source: FDA MedWatch)
Source: FDA MedWatch - August 7, 2015 Category: American Health Source Type: news
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events
Increased rate of pump thrombosis, high rate of stroke, bleeding complications. (Source: FDA MedWatch)
Source: FDA MedWatch - August 5, 2015 Category: American Health Source Type: news
Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection
Cases of PML in two patients with no prior exposure to immunosuppressant drugs. (Source: FDA MedWatch)
Source: FDA MedWatch - August 4, 2015 Category: American Health Source Type: news
Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing
Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection. (Source: FDA MedWatch)
Source: FDA MedWatch - August 4, 2015 Category: American Health Source Type: news
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). (Source: FDA MedWatch)
Source: FDA MedWatch - August 1, 2015 Category: American Health Source Type: news
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities
The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies. (Source: FDA MedWatch)
Source: FDA MedWatch - July 31, 2015 Category: American Health Source Type: news
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. (Source: FDA MedWatch)
Source: FDA MedWatch - July 31, 2015 Category: American Health Source Type: news
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion
FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor). (Source: FDA MedWatch)
Source: FDA MedWatch - July 30, 2015 Category: American Health Source Type: news
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. (Source: FDA MedWatch)
Source: FDA MedWatch - July 27, 2015 Category: American Health Source Type: news
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use
Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. (Source: FDA MedWatch)
Source: FDA MedWatch - July 27, 2015 Category: American Health Source Type: news
