This recall affects the following lots of 0.9% Sodium Chloride Injection USP in 100 m L MINI-BAG PLUS Container: Product Code NDC Number Lot # Expiration Date 2B0043 0338-0553-18 P3178 2B0043 0338-0553-18 P3178 Unaffected lot numbers can continue to be used according to the instructions for use.According to the 0.9% Sodium Chloride Injection USP in 100 m L MINI-BAG PLUS Container product labeling, the product should be inspected visually for particulate matter and discoloration whenever solution and container permit.Do not administer unless solution is clear, free from visible particles and the seal is intact Do not remove unit from overwrap until ready for use.The inner bag maintains the sterility of the solution.
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.
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).
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of a.m.
Sodium Chloride Intravenous Infusion BP 0.9% w/v is of value as a source of water and electrolytes and is indicated for replenishing fluid and for restoring and maintaining the concentrations of sodium and chloride ions.
When used in conjunction with cell separator procedures, the solution is contraindicated in those patients where adequate anticoagulation cannot be achieved.