Fixed Core Wire Guide recalled over foreign material

Recall date

October 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cook Inc. recalls Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured…

Recall number

Z-0399-2021

FDA classification

Class I

Brand / firm

Cook Inc.

Sold / distributed

US distribution to AZ, IA, IN, MA, and ND.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.