Medline's ACME Monaco guidewire recall is Class I

The FDA classifies the recall of Medline Industries' ACME Monaco catheter guidewire as Class I, denoting the risk of serious injury or death. The FDA categorized Medline Industries' recall of its ACME Monaco guidewire as Class I, denoting the risk of serious injury or death. The recall of the ACME Monaco guidewire, designed to direct a percutaneous catheter through a blood vessel, was 1st initiated in August 2013 on the potential for the guidewire's coating to flake off. Food & Drug Administration (FDA), Medline Industries Inc.News Well, Catheters, Recallsread more
Source: Mass Device - Category: Medical Equipment Authors: Source Type: news