July 8th, 2011

CONTRAINDICATION: Weck Hem-o-Lok Ligating Clips

The FDA issued a notification to health care providers that Weck Hem-o-Lok may create serious risks to donors when used in laparoscopic living-donor nephrectomies. The clips can become dislodged, causing serious injury or death.

CONTRAINDICATION: Weck Hem-o-Lok Ligating Clips

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RECALL: Inaccurate Electrolyte Results From Synchron LX “ISE” Flow Cell

August 5th, 2011

Healthcare professionals were notified that incorrect electrolyte results may be caused by ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell). Many serious adverse health events may occur as a result. RECALL: Inaccurate Electrolyte Results from Synchron LX “ISE” Flow Cell...

RECALL: Misleading Packaging on Pentrexyl Forte Natural

August 2nd, 2011

Both the FDA and Phoenix Import & Distribution LLC have issued a public recall on Pentrexyl Forte Natural. The reason for the recall is that the packaging of Pentrexyl Forte Natural is believed to be misleading, which can cause it to be confused with certain antibiotic medications.  Pentrexyl Forte Natural is only a Dietary Supplement and contains no antibiotics. Thus, Ill individuals taking this supplement may accidentally delay treatment for serious illnesses. RECALL: Misleading Packaging on Pentrexyl Forte Natural...

FDA PUBLIC HEALTH NOTIFICATION: SimplyThick May Potentially Cause Fatal Infant Bowel Condition

July 29th, 2011

The FDA notified parents, caregivers and health care providers not to feed SimplyThick to infants born before 37 weeks. The thickening agent, used for management of swallowing disorders, can lead to necrotizing enterocolitis (NEC) in infants, a potentially fatal condition that causes inflammation and death of intestinal tissue. FDA PUBLIC HEALTH NOTIFICATION: SimplyThick may Potentially cause Fatal Infant Bowel Condition...