FDA-Device2020-11-11Class I
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.
Cook Inc.
Hazard
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.
Sold states
US distribution to AZ, IA, IN, MA, and ND.
Affected count
61 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2021Don't want to check this manually?
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