FDA-Device2022-10-05Class II
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
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
202 US; 11 OUS
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1839-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief