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When Sodium Chloride 0.9 % is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will also be dictated by the nature and the dose regimen of the prescribed drug.The solution is for administration by intravenous infusion through a sterile and non-pyrogenic administration set, using aseptic technique.For information on incompatibilities and preparation of the product (with additives), please see sections 6.2 and 6.6.This product must be used with caution in patients with an impaired ability to handle sodium such as organic heart disease especially with a history of congestive heart failure, patients with renal insufficiency, cirrhosis of the liver, cardiopulmonary diseases or patients receiving salt retaining steroids.
Additives may be introduced before infusion or during infusion through the injection site.
Baxter has notified customers, who are being directed not to use product from the recalled lots.
Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of a.m. Unaffected lots of product are available for replacement. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.
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.