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.
Medline advised customers to check for surgical kits affected by the recall, for lots 054372-1-1A, 054372-1-1B and 054372-1-2A, and return any of affected devices to the company, according to the FDA.
"The rest of the kit may be used and the affected guidewire may be replaced with a sterile product from supply," the agency said.
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