FDAFDA · Food and drugs·Recall number Z-1842-2022
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
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
- THSCF-35-220-1.5-ROSEN G01623 UDI-DI: 00827002016231 Lots/Expiration Date: 14818344 29-06-2027 14820965 30-06-2027 14849857 20-07-2027 THSCF-35-80-1.5-ROSEN G01774 UDI-DI: 00827002017740 Lots/Expiration Date: 14820960 30-06-2027 14832877 08-07-2027 14847945 19-07-2027 THSCF-35-180-1.5-ROSEN G01264 UDI-DI: 00827002012646 Lots/Expiration Date: 14820961 30-06-2027 14843133 15-07-2027 14847946 19-07-2027 THSCF-35-145-1.5-ROSEN G01261 UDI-DI: 00827002012615 Lots/Expiration Date: 14820962 30-06-2027 14820963 30-06-2027 14820964 30-06-2027 14828587 06-07-2027 14835364 11-07-2027 14835365 11-07-2027 14849859 20-07-2027
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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