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Baxter Issues Urgent Medical Device Correction for Novum IQ Syringe Infusion Pump Due to Potential Impact of Downstream Occlusions on Infusion Volume

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. The Correction is due to the potential for an incomplete infusion following one or more downstream occlusion alarms. Baxter notified impacted customers in October and i

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-novum-iq-syringe-infusion-pump-due-potential-impact

 
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Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers

Recommendations for health care providers due to potential procedural outcome differences between women and men undergoing procedures with LAAO devices.

http://www.fda.gov/medical-devices/letters-health-care-providers/left-atrial-appendage-occlusion-laao-devices-potentially-associated-procedural-outcome-differences

 
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Meta Herbal Issues Voluntary Nationwide Recall of Magnum XXL 9800 Capsules Due to Presence of Undeclared Sildenafil

E. Hampton NY- Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products f

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared

 
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Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication – FDA Warns of Rare but Serious Drug Reaction

The FDA is warning that the antiseizure medicines can cause a rare but serious reaction, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that can be life-threatening if not diagnosed and treated quickly.

http://www.fda.gov/safety/medical-product-safety-information/antiseizure-medicines-keppra-keppra-xr-elepsia-xr-spritam-levetiracetam-and-onfi-sympazan-clobazam