FDAFDA · Food and drugs·Recall number Z-1835-2022
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
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
- THDOC-35-60-0-3 G11949 UDI-DI: 00827002119499 Lots/Expiration Dates: 14797780 16-06-2027 C-HDOC-18-40-0-2 G09201 UDI-DI: 00827002092013 Lots/Expiration Dates: NS14807603 22-06-2027 C-THDOC-18-40-0-2-HTS G26925 UDI-DI: 00827002269255 Lots/Expiration Dates: NS14818388 29-06-2027
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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