Archive for the ‘FDA Warning’ Category

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...

New Prescription Restrictions for Avandia (Rosiglitazone), Avandamet, Avandaryl

July 26th, 2011

Due to new restrictions to the prescribing and use of rosiglitazone-containing medications, the FDA has issued a notification to healthcare professionals and the public. Rosiglitazone, used to treat type II diabetes, is sold as Avandia, Avandamet, and Avandaryl. The REMS previously consisted of only a Medication Guide, but now include a “restricted access and distribution program,” and applies to all three rosiglitazone products. New Prescription Restrictions for Avandia (rosiglitazone), Avandamet, Avandaryl ...

Slim Xtreme Herbal Slimming Capsule – Contains Undeclared Amounts of Sibutramine (Withdrawn for Safety Concerns)

July 22nd, 2011

Slim Xtreme Herbal Slimming Capsules (30 Capsules/Bottle, all lots), have been recalled. Headquartered in Hollywood, Florida, the company sold its product nationwide via the internet. The product was found to contain sibutramine, a controlled substance withdrawn from American markets in October 2010 for cardiovascular health risks. Slim Xtreme Herbal Slimming Capsule - Contains undeclared amounts of sibutramine (withdrawn for safety concerns)...

RECALL: Defibtech Lifeline, ReviveR Automated External Defibrillators (AEDs) – Software Glitch

July 19th, 2011

Due to a software glitch in Model DDU-100 series Defibrillators running software version 2.004 or earlier (branded as Lifeline, ReviveR), the devices may cancel shock during the charging process. This can result in a failure to resuscitate a patient in emergency situations. RECALL: Defibtech Lifeline, ReviveR Automated External Defibrillators (AEDs) - Software glitch...

RECALL: Multi-Mex Dietary Supplements – Product Packaging Confusingly Similar to Over-the-Counter Antibiotics

July 15th, 2011

After inspection by the FDA, a recall was initiated for select Multi-Mex dietary supplements for its packaging, which mimics antibiotics readily available in Mexico and may be confusingly similar when viewed by Hispanic consumers. The confusion can lead to patients not receiving the antibiotic medications they need for treatment. RECALL: Multi-Mex Dietary Supplements - Product pkg confusingly similar to over-the-counter antibiotics...

Needleless Pre-filled Glass Syringes Not Compatible With Some Intravenous Access Systems

July 12th, 2011

The FDA is advising healthcare professionals, especially those in critical care positions, to avoid the use of needleless adenosine and amiodarone pre-filled glass syringes, since they are known to be incompatible with select IV access systems. Needleless Pre-filled Glass Syringes not compatible with some IV access systems...

CONTRAINDICATION: Weck Hem-o-Lok Ligating Clips

July 8th, 2011

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...

Boston Scientific – Stolen Shipment of Non-Sterile Women’s Health Medical Devices

July 5th, 2011

The FDA and Boston Scientific Corp. have reported that a shipment of Endoscopy and Urology women’s health medical devices have been stolen while being sent to Boston Scientific’s sterilization facility during the second week of April. These instruments, despite their labeling, are not sterilized, and can lead to infection if used. Boston Scientific - Stolen shipment of non-sterile women’s health medical devices...