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Moderate riskFDA DeviceClass II

Cook Medical Approach CTO-12 Micro Wire Guide recalled for incorrect expiration dates

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.

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

What to do

  1. Check if you have any Cook Medical Approach CTO-12 Micro Wire Guide devices with lot numbers 15885574X, 15783003X, or 15416547
  2. Do not use devices from these lots
  3. Contact Cook Medical or your supplier for replacement or disposal instructions
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
49 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1776-2026

In the FDA's words

Description
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 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)281203(10)15783003X, Lot Number 15783003X; Reference Part Number CMW-14-300-12G, UDI (01)00827002507913(17)260227(10)15416547, Lot Number 15416547. Distribution: Worldwide distribution. Affected quantity: 49 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.

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Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device