# FDA recall Z-1709-2022

> **Cook Incorporated** · Class II · device recall initiated 2022-07-19.

## Product

Roadrunner PC Hydrophilic Wire Guide    REFERENCE PART NUMBER (RPN): RPC-35-180  ORDER NUMBER (GPN):G07518.   For vascular catheter positioning and exchange in diagnostic and interventional procedures.

## Reason for recall

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

## Distribution

Nationwide Foreign: AR AT AU BE  BG CA CA  CH CL CN CZ  DE  DK ES  FR  GB GR  GU HU  IL IT  JO  JP KR KW MX MY NC NL PE PL PR PT  PY RU  SE SI TR UY ZA

## Key facts

- **Recall number:** Z-1709-2022
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-19
- **Report date:** 2022-09-21

- **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-1709-2022

## Citation

> AI Analytics. FDA recall Z-1709-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1709-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*