FDAFDA · Food and drugs·Recall number Z-1825-2022
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
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
- TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827, Lots 14797763 14797770 14805076 14805079 14813709 14813711; TSFBP-35-145 (GPN G09735) UDI-DI 00827002097353, Lots 14807595 14812037 14812038
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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