# FDA recall Z-1837-2022

> **Cook Incorporated** · Class II · device recall initiated 2022-08-16.

## Product

Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire  Reference Part Number/GPN:  RPC-035145-0-5	G34131  RPC-035145	G18154  RPC-035145-5	G34132  RPC-038145-0-5	G34129  RFSPC-038145-0	G17539  RFSPC-035145	G17540  RPC-038145-0	G18155  RPC-035145-0	G18153  RFSPC-035145-0	G17542

## Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-1837-2022
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-16
- **Report date:** 2022-10-05

- **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-1837-2022

## Citation

> AI Analytics. FDA recall Z-1837-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1837-2022. Source: US FDA. Licensed CC0.

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