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Latest Medical Device News

• Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle - Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.
• Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices - The counterfeit version of Avastin does not contain the medicine?s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.
• Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up - During packaging and labeling, tablets from one product type may have carried over into packaging of another product.
• H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination - UPDATED 02/08/2012. NAR Surgical Crichothyroidotomy (Crickit) Kits recalled. Use of contaminated Povidone Prep Pads could lead to life-threatening infections.
• Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective - Products could potentially expose users and patients to unnecessary and potentially harmful X-rays.
• Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient - UPDATED 02/22/2012. Recall expanded to include all lots purchased on or before October 25, 2011. Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
• Infants? TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints - Reports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe.
• January 2012 - Monthly Safety Labeling Changes includes 63 products with revisions to Prescribing Information.
• Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets - Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
• Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards - Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.
• Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridium Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs - Symptoms may include watery stool, abdominal pain, and fever. Patients may go on to develop more serious intestinal conditions.
• RegenArouse: Recall - Undeclared Drug Ingredient - Product marketed as dietary supplement contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
• Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended Pressure - The humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient.
• Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries - Brush head may break off in the user?s mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes.
• Treanda (bendamustine HCL): Recall - Particulate Matter in Vial - Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
• Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) - The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.
• Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination - Possibility of an adverse reaction or unknown drug-drug interaction.
• Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions - Interactions between Victrelis and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.
• Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans - Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
• Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall - Non-Sterile Products - Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.