🔍 RecallPedia

Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

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:
    RFSPC-35-145 G09607 UDI-DI: 00827002096073 Lot/Expiration Date: 14831437 07-07-2025 14831438 07-07-2025 14835040 11-07-2025 14840287 13-07-2025 14840288 13-07-2025 14840309 13-07-2025
  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 Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

Product Codes/Lot Numbers:

RFSPC-35-145 G09607 UDI-DI: 00827002096073 Lot/Expiration Date: 14831437 07-07-2025 14831438 07-07-2025 14835040 11-07-2025 14840287 13-07-2025 14840288 13-07-2025 14840309 13-07-2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1838-2022

Related Recalls