Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Class I - DangerousWhat Should You Do?
- Check if you have this product: RPC-35-145 G06979 UDI-DI: 00827002069794 Lots/Expiration Date: 14774168 07-06-2025 14810021 23-06-2025 14813491 27-06-2025 14816228 28-06-2025 14835046 11-07-2025 14835049 11-07-2025 14845506 18-07-2025 NS14813489 27-06-2025 NS14813489X 27-06-2025 RPC-35-80 G09534 UDI-DI: 00827002095342 Lots/Expiration Date: 14823405 01-07-2025 14823407 01-07-2025 14823408 01-07-2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Product Codes/Lot Numbers:
RPC-35-145 G06979 UDI-DI: 00827002069794 Lots/Expiration Date: 14774168 07-06-2025 14810021 23-06-2025 14813491 27-06-2025 14816228 28-06-2025 14835046 11-07-2025 14835049 11-07-2025 14845506 18-07-2025 NS14813489 27-06-2025 NS14813489X 27-06-2025 RPC-35-80 G09534 UDI-DI: 00827002095342 Lots/Expiration Date: 14823405 01-07-2025 14823407 01-07-2025 14823408 01-07-2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1841-2022
Related Recalls
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Incorporated
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.