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Baxter has notified customers, who are being directed not to use product from the recalled lots.
Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter As published by the FDA FOR IMMEDIATE RELEASE – December 11, 2014 – DEERFIELD, Ill. announced today it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 m L MINI-BAG PLUS Container to the hospital/user level.
Adults, older people and children: Doses may be expressed in terms of m Eq or mmol of sodium, mass of sodium, or mass of sodium salt (1 g Na Cl = 394 mg, 17.1 m Eq or 17.1 mmol of Na and Cl).
Fluid balance, serum electrolytes and acid-base balance should be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).
The extent and severity of harm depends on the size, number, and composition of the foreign material, and the patient’s underlying medical condition.
In the absence of in-line filtration, particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization (blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver).