Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
US distribution to AZ, IA, IN, MA, and ND.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2021