Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay in the skin after injection.
The recalled AccuSure insulin Syringes were distributed to wholesale and retail pharmacies nationwide between January 2002 and October 2009. Anyone who has AccuSure insulin syringes should stop using them. For more information , call Qualitest at 1-800-444-4011.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
Pointe Scientific has recalled certain lots of its Liquid Glucose Hexokinase Reagent. These reagents have failed to produce accurate results at glucose values above 200 mg/dL. A list of the affected lot numbers can be found below. The company is instructing distributors and testing laboratories to destroy any of the recalled products that remain in their inventories. Laboratories should consider all test results obtained with the recalled reagents to be questionable and consult with the patient’s physician about whether re-testing will be required.
KTM, maker of the defective off road motorcycle, conducted a voluntarily RECALL OF THE 2009 OFF ROAD MOTORCYCLES, in cooperation with The Consumer Product and Safety Commission. The recall was initiated because of the undue risk for injury or death from the motorcycle’s front fork failure. Consumers are advised to immediately stop using the off road motorcycle.
The KTM recall involves approximately 550 2009 Off Road Motorcycle models in orange and black, including: 125SX, 150SX, 250XC-W, and 300XC-W. The defective models were manufactured in Austria and sold in the U.S. from December of 2008 through April 2009. The hazard that has been identified is associated with the front fork inner tube. The front fork inner tube may crack and dislodge from the fork axle. The breakage of the inner tube poses a risk of injury or death to the driver or people surrounding the driver at the time of the breakage. The off road motorcycle costs between $6000. and $8000. Consumers are advised to immediately stop using the off road motorcycle, contact KTM at (888) 985-6090 for a free repair, or visit the KTM North America Inc., of Amherst, Ohio website.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
Philips Healthcare is recalling the company’s Avalon fetal monitors because of an increase in inaccurate readings. As a result, users may fail to identify fetal distress, fail to perform needed interventions, or perform unnecessary interventions such as cesarean delivery. All of these could result in serious injury or death to the mother and fetus.
Increased inaccuracies have included switching between the fetal and maternal heart rates, doubling or halving of the fetal heart rate, false decelerations, a mismatch between the audible and printed readings, and noisy or erratic signals.
The affected models are the FM20, FM30, FM40 and FM50. Philips is not removing them from the market at this time. While the company continues to investigate this situation, it recommends several interim steps to reduce the likelihood of inaccurate readings or their impact.
These include using the monitor’s cross-channel verification feature to differentiate between the fetal and maternal heart rates, and, when in doubt, confirming the fetal heart rate with ultrasound imaging or fetal scalp electrodes.
The company also recommends that users recognize situations that can increase the likelihood of inaccurate readings. These include contractions, maternal tachycardia, fetal or maternal movement, and maternal pushing, coughing or vomiting.
Video originally created by FDA -- posted by Lawsuit.com on December 10, 2009
Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient’s airway. This could make it difficult to manually ventilate a patient, and lead to ineffective ventilation. Also, the indicator paper might not change color, so the operator can’t detect changes in CO2 levels.
The recall affects about 80 lots of these devices. In August, the company sent letters to its customers, advising them to review their inventory and return all devices from the affected lots.
