FDA slaps Class I label on rapid infuser recall

The FDA today declared that the recall of an emergency infusion device kit is the most serious type.

The recall covers three models of disposable sets made by Smisson-Cartledge Biomedical for its ThermaCor 1200 rapid infuser, which is used for fluid or bolus delivery. The system is made of a footswitch for hands-free fluid control, a fluid delivery device and a single-use disposable set with supply lines that can be used with intravenous (IV) bags or surgical equipment, according to the FDA.

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