FDA-Device2026-04-15Class II

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

Cook Incorporated
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Sold states
Worldwide distribution.
Affected count
15 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2026

Original summary

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005 Distribution: Worldwide distribution. Affected quantity: 15 units

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