Reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products.
Entries Tagged as 'FDA Alerts'
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
December 11th, 2008 · No Comments
Tags: FDA · FDA Alerts
Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences
December 11th, 2008 · No Comments
Recall issued because the devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.
Tags: FDA · FDA Alerts
Healon D Ophthalmic Viscosurgical Device
December 11th, 2008 · No Comments
Recall of one lot of the product because some of the tested OVD syringes had endotoxin levels above the required limit.
Tags: FDA · FDA Alerts
20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP
December 9th, 2008 · No Comments
Recall of one lot due to possible incorrect bar code for 5% Dextrose Injection, USP. The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication.
Tags: FDA · FDA Alerts
Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae
December 8th, 2008 · No Comments
Worldwide recall involving 21 lot codes, due to reports of difficulty retracting the introducer from the cannula.
Tags: FDA · FDA Alerts