General Recalls

Recalls

A catheter used for various treatments at medical facilities has been recalled by the Food and Drug Administration (FDA) as part of a Class 1 recall. A class 1 recall is the most serious type of action issued by the FDA and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.




Recalls

The Centers for disease Control (CDC) has recalled 800,000 pre-filled injectable H1N1 vaccines designated for children between 6 months and 35 months old because the agent in the vaccine that produces the immune response to the virus is not as potent as was desired, according to WBRC-TV in Birmingham, Ala.




Recalls

Psychiatric healthcare professionals are being alerted by the Food and Drug Administration (FDA) that Norpramin (desipramine hydrochloride),a medication used to treat depression, should be used with extreme caution with patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The new WARNINGS and OVERDOSAGE sections also include a warning that seizures precede cardiac dysrhythmias and death in some patients.




Recalls

Medical technology company Stryker Corporation is recalling 23 surgical navigation systems because of the potential for the machines to stop working, which could potentially lead to serious adverse consequences for patients, including death, according to an announcement by the Food and Drug Administration (FDA).




Recalls

Three lots of Vicks Sinex nasal spray is being recalled in the United States, Germany and the United Kingdom after analysis found the bacteria B. cepacia in a small amount of the product made at a manufacturing plant at Gross Gerau, Germany. The bacteria could cause serious infections for individuals with compromised immune systems or those with chronic lung conditions such as cystic fibrosis.




Recalls

More dietary supplement products designed to increase muscle mass are being recalled after an analysis by the Food and Drug Administration (FDA) identified undeclared substances that it considers to be steroids, including Madol, Turinabol, Superdrol, and/or Androstenedione. The latest recall covers IDS Sports products sold under the brand names Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR.




Recalls

A sheath designed to facilitate the entry of an intravascular device through the skin is being recalled by the Food and Drug Administration (FDA) because the device may be fractured, which may require unplanned open surgery to remove the retained segments or control bleeding. The recall includes all lots of the ViperSheath Sheath Introducer made by Thomas Medical and distributed by Cardiovascular Systems, Inc. (CSI).




Recalls

New data indicates that omeprazole (Prilosec/Prilosec OTC), a medicine used to reduce stomach acid, also reduces the anti-blood clotting effect of clopidogrel (Plavix), a medication taken by patients at risk for heart attacks or stroke, by almost half when the two drugs are taken by the same patient, according to a new Public Health Advisory issued by the Food and Drug Administration (FDA). This drug interaction occurs because omeprazole blocks the conversion of clopidogrel into its active form. The interaction is not reduced if the doses of clopidogrel and omeprazole are separated with time.




Recalls

The U. S. Consumer Product Safety Commission (CPSC) is alerting the public, school officials, facilities managers, and municipal and public safety officials that outdoor steel stadium light poles manufactured by Whitco Co. LP, of Fort Worth, Texas can fracture or crack and fall over, posing a risk of serious injury and death to patrons and bystanders from being hit or crushed. To reduce the risk of injury, Whitco Co. LP outdoor steel stadium light poles should be inspected immediately.