Baxter recalls broken saline vials
During “standard visual inspection prior to patient administration” users noticed fragments in 100 ml mini-bags of 0.9% Sodium Chloride Injection, belonging to lots P317842 and P317891.
A Baxter spokeswoman told in-Pharmatechnologist.com the particles had broken off the vial adapter, a tool which fits between vial and syringe to prevent needle-stick injuries.
The lots had reached the US market and have been voluntarily recalled at hospital/user level.
The US Food and Drug Administration (FDA) warned intravenous administration of a solution containing sterile particulates can have adverse effects.
“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 pre-existing 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).”
No ill effects were reported for the affected Baxter lots.
The Sodium Chloride injections are made for IV administration after mixing with a single dose powdered drug.
Unaffected lots can continue to be used, according to the FDA.
According to the product’s label, it should be inspected visually for particulate matter and discoloration whenever possible.
