FDAFDA · Food and drugs·Recall number Z-1840-2022
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Published October 5, 2022 · Recall initiated: August 16, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot
- RLPC-35-145 G06866 UDI-DI: 00827002068667 Lots/Expiration Date: 14828631 06-07-2025 14828643 06-07-2025 14828644 06-07-2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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