🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 16, 2022 Cook Incorporated Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    RPC-035145-0-5 G34131 UDI-DI: 00827002341319 Lot/Expiration Date: 14769270X 03-06-2025 14802181 20-06-2025 14816224 28-06-2025 14818488 29-06-2025 14818489 29-06-2025 14828627 06-07-2025 14828629 06-07-2025 RPC-035145 G18154 UDI-DI: 00827002181540 Lot/Expiration Date: 14770863 06-06-2025 14770864 06-06-2025 14813490 27-06-2025 14816227 28-06-2025 NS14770866 06-06-2025 NS14804982 21-06-2025 RPC-035145-5 G34132 UDI-DI: 00827002341326 Lot/Expiration Date: 14770872 06-06-2025 14810022 23-06-2025 14831440 07-07-2025 RPC-038145-0-5 G34129 UDI-DI: 00827002341296 Lot/Expiration Date: 14804972 21-06-2025 14809971 23-06-2025 RFSPC-038145-0 G17539 UDI-DI: 00827002175396 Lot/Expiration Date: 14809157 23-06-2025 14837048 12-07-2025 RFSPC-035145 G17540 UDI-DI: 00827002175402 Lot/Expiration Date: 14818484 29-06-2025 14818485 29-06-2025 14818490 29-06-2025 14840310 13-07-2025 RPC-038145-0 G18155 UDI-DI: 00827002181557 Lot/Expiration Date: 14819269 29-06-2025 14823406 01-07-2025 14832976 08-07-2025 NS14828649 06-07-2025 RPC-035145-0 G18153 UDI-DI: 00827002181533 Lot/Expiration Date: 14828625 06-07-2025 14828630 06-07-2025 14828635 06-07-2025 14828636 06-07-2025 14828637 06-07-2025 14828640 06-07-2025 14828641 06-07-2025 14841469 14-07-2025 NS14813479 27-06-2025 NS14818486 29-06-2025 RFSPC-035145-0 G17542 UDI-DI: 00827002175426 Lot/Expiration Date: 14844152 15-07-2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cook Incorporated
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

RPC-035145-0-5 G34131 UDI-DI: 00827002341319 Lot/Expiration Date: 14769270X 03-06-2025 14802181 20-06-2025 14816224 28-06-2025 14818488 29-06-2025 14818489 29-06-2025 14828627 06-07-2025 14828629 06-07-2025 RPC-035145 G18154 UDI-DI: 00827002181540 Lot/Expiration Date: 14770863 06-06-2025 14770864 06-06-2025 14813490 27-06-2025 14816227 28-06-2025 NS14770866 06-06-2025 NS14804982 21-06-2025 RPC-035145-5 G34132 UDI-DI: 00827002341326 Lot/Expiration Date: 14770872 06-06-2025 14810022 23-06-2025 14831440 07-07-2025 RPC-038145-0-5 G34129 UDI-DI: 00827002341296 Lot/Expiration Date: 14804972 21-06-2025 14809971 23-06-2025 RFSPC-038145-0 G17539 UDI-DI: 00827002175396 Lot/Expiration Date: 14809157 23-06-2025 14837048 12-07-2025 RFSPC-035145 G17540 UDI-DI: 00827002175402 Lot/Expiration Date: 14818484 29-06-2025 14818485 29-06-2025 14818490 29-06-2025 14840310 13-07-2025 RPC-038145-0 G18155 UDI-DI: 00827002181557 Lot/Expiration Date: 14819269 29-06-2025 14823406 01-07-2025 14832976 08-07-2025 NS14828649 06-07-2025 RPC-035145-0 G18153 UDI-DI: 00827002181533 Lot/Expiration Date: 14828625 06-07-2025 14828630 06-07-2025 14828635 06-07-2025 14828636 06-07-2025 14828637 06-07-2025 14828640 06-07-2025 14828641 06-07-2025 14841469 14-07-2025 NS14813479 27-06-2025 NS14818486 29-06-2025 RFSPC-035145-0 G17542 UDI-DI: 00827002175426 Lot/Expiration Date: 14844152 15-07-2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1837-2022

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