# FDA recall Z-0963-2020

> **Cook Inc.** · Class II · device recall initiated 2019-01-04.

## Product

Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

## Reason for recall

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

## Distribution

Domestic distribution to nationwide US.    Foreign distribution to Australia, Belgium,  Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic,  Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India,  Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia,  Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto  Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan,  Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

## Key facts

- **Recall number:** Z-0963-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-04
- **Report date:** 2020-02-12
- **Termination date:** 2020-05-29

- **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-0963-2020

## Citation

> AI Analytics. FDA recall Z-0963-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0963-2020. Source: US FDA. Licensed CC0.

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