FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Approach CTO-12 Micro Wire Guide recalled for incorrect expiration dates
What this means
Cook Medical's Approach CTO-12 Micro Wire Guide devices in three affected lots have expiration dates printed on the packaging that go beyond when the devices actually expire. This could lead to use of degraded or ineffective devices. No injuries have been reported.
- Check if you have any Cook Medical Approach CTO-12 Micro Wire Guide devices with lot numbers 15885574X, 15783003X, or 15416547
- Do not use devices from these lots
- Contact Cook Medical or your supplier for replacement or disposal instructions
The agency's original wording
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
49 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2026Want us to check the next one for you?
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