FDA-Device2026-04-15Class IIMISBRANDING

COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

EXPIRATION DATE ERRORNationwide distribution
Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Sold states
Worldwide distribution.
Affected count
75 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1777-2026

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