FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Approach CTO-6 Micro Wire Guide recalled for incorrect expiration dates
What this means
Cook Medical's Approach CTO-6 Micro Wire Guide (Part CMW-14-190-6G, Lot 15288005) was labeled with expiration dates that go beyond when the device actually expires. This means the device may no longer be safe or effective to use after the true expiration date, even though the label says it is still good.
- If you have this device (Lot 15288005), stop using it immediately
- Contact Cook Medical or your supplier for instructions on returning or replacing the affected units
- Do not use this device past its true shelf life, even if the label shows a later date
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
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-1775-2026Want us to check the next one for you?
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