Archive | October, 2009
Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall
Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.
Continue reading...Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall
27. October 2009
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Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use.
Continue reading...Peramivir IV
24. October 2009
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Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers.
Continue reading...Rituxan (rituximab) – PML
23. October 2009
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Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist.
Continue reading...Medical Device Power Cords Safety Investigation: Initial Communication
19. October 2009
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Reports of sparking, charring, and fires from device power cords.
Continue reading...Tamiflu (oseltamivir) for Oral Suspension
16. October 2009
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UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet.
Continue reading...Dexferrum (iron dextran injection) – Labeling Change
16. October 2009
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Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.
Continue reading...Relenza (zanamivir) Inhalation Powder
9. October 2009
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Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator.
Continue reading...Philips Heartstart Fr2+ Automated External Defibrillators – Recall
5. October 2009
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Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated.
Continue reading...Neuron 6F 070 Delivery Catheter [Penumbra]
1. October 2009
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Field removal of the catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter
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30. October 2009
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