FDA-Device2022-10-05Class II
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
Cook Incorporated
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.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
1,236 US
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1828-2022Don't want to check this manually?
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