FDA-Device2026-04-15Class II

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

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

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

Original summary

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 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204. Distribution: Worldwide distribution. Affected quantity: 75 units

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