Archive | November, 2009
Stryker Operating Room System II Surgical Navigation System – Recall
A potential for the navigation PC SPC-1 component to stop working which could result in potential harms associated with this failure.
Continue reading...Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review
20. November 2009
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FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo.
Continue reading...Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication
19. November 2009
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Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use.
Continue reading...Vicks Sinex Nasal Spray – Recall
19. November 2009
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Product found containing the bacteria B. cepacia.
Continue reading...RockHard Weekend – product contains undeclared drug ingredient
18. November 2009
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Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil.
Continue reading...Cardiovascular Systems ViperSheath Sheath Introducer – Recall
17. November 2009
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Nationwide recall due to stretching or fracture of the sheath during use.
Continue reading...IDS Sports Dietary Supplements – Recall
17. November 2009
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Five products marketed as dietary supplements contain undeclared substances considered to be steroids.
Continue reading...Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) – Drug Interaction
17. November 2009
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Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole.
Continue reading...Pai You Guo, Marketed as Dietary Supplement – Recall
13. November 2009
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Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein.
Continue reading...Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) – Chondrolysis
13. November 2009
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Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices.
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27. November 2009
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