# FDA recall Z-0399-2021

> **Cook Inc.** · Class I · device recall initiated 2020-10-22.

## Product

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.

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-0399-2021
- **Recalling firm:** Cook Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-22
- **Report date:** 2020-11-11
- **Termination date:** 2021-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2021

## Citation

> AI Analytics. FDA recall Z-0399-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0399-2021. Source: US FDA. Licensed CC0.

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