Recall Weekly
Moderate riskFDA DeviceClass II

Cook Medical Approach CTO-6 Micro Wire Guide recalled for incorrect expiration dates

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.

From the FDA notice · Read the official notice ↗ · All Cook recalls

What to do

  1. If you have this device (Lot 15288005), stop using it immediately
  2. Contact Cook Medical or your supplier for instructions on returning or replacing the affected units
  3. Do not use this device past its true shelf life, even if the label shows a later date
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
15 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1775-2026

In the FDA's words

Description
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005 Distribution: Worldwide distribution. Affected quantity: 15 units
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

18 products in this recall

Cook Medical procedure kits recalled for expiration date errors

Cook Medical is recalling 18 product listings, including catheter, tracheostomy, and central venous kits and trays, because some affected lots were labeled with expiration dates longer than their true shelf life. No injuries have been reported, and the products were distributed worldwide.

The agency lists each product separately. Check every one you might have.

More from Cook

See all

Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device