Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Fixed Core Wire Guide Recalled by Cook Inc. Due to Affected product was dropped during manufacturing, which may...

Date: October 22, 2020
Company: Cook Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cook Inc. directly.

Affected 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.

Quantity: 61 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 5 states: AZ, IN, IA, MA, ND

Affected (5 states)Not affected

About Cook Inc.

Cook Inc. has 262 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report