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Medical Daily
Medical Daily
Health
Elena Vega

Recalled Saline Flush Ampules Used on IV Lines and Ports Receive FDA's Most Serious Rating Over Sterility Concerns

The Food and Drug Administration has identified the recall of certain sodium chloride flush ampules used to clear IV tubing and catheters as the most serious type of recall. The Sept. 18 designation applies to 10-milliliter ampules of 0.9% sodium chloride sold by Spectra Medical Devices and made by South Korean manufacturer Huons Co., Ltd.

The ampules are used to flush IV tubing and devices that stay in a patient's veins, such as central lines and implanted ports. The FDA's recall notice warns that the device "may cause serious injury or death if you continue to use it."

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