Source: QMED – Qualified Suppliers to the Medical Device Industry
“The FDA last month designated a Medline Industries guidewires recall as Class I.
The Medline guidewire is identified as the ACME Monaco Guidewire .035×150 3MMJ TCFC item number 88241, with affected products distributed between March 2013 and August 2013.
The guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries. It is meant to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
The guidewires in question, however, have the potential for the coating to flake off of the wire, according to the FDA.”
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