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Recall Observatory FDA recall evidence

Device product

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

Z-1775-2026

March 05, 2026

Class II

Product summary

Firm
Cook Incorporated
Event
Event 98495
Status
Ongoing
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-1775-2026

Official wording

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

Code information: UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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