FDA-Device2022-10-05Class II
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
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
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1846-2022Don'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