FDA-Device2022-10-05Class II
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
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
115 US
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1840-2022Don't want to check this manually?
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