FDA-Device2022-10-05Class II
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
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
No distribution (Distribution Center only)
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2022Don't want to check this manually?
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