February 25, 2019

FDA: Class I recall of ICU Medical’s ChemoLock Vial Spike

By: Judy Mathias

Editor’s Note

The Food & Drug Administration (FDA) on February 22 identified the recall by ICU Medical (San Clemente, California) of its ChemoLock Vial Spike (20 mm) as Class I, the most serious.

The recall was initiated because of the potential for plastic particles to break off the protective cap. The plastic particles could be infused into a patient’s IV line, which could lead to embolism, serious injury, or death.

The Lot Number is 3757712. Distribution dates are August 2018 to September 2018.


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