Recall Weekly
Moderate riskFDA DeviceClass II

Cook Medical Staged Extubation Set recalled for incorrect expiration dates

Cook Medical's Staged Extubation Set (Part Number C-CAE-14.0-83-EXTU, Lot 16010654) was labeled with expiration dates that go beyond when the device is actually safe to use. About 95 units were distributed worldwide. No injuries have been reported.

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

What to do

  1. Check your inventory for Lot Number 16010654
  2. Do not use units beyond their true shelf life
  3. Contact Cook Medical or your distributor for guidance on affected units
  4. Verify actual product shelf life with the manufacturer before use
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
95 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1782-2026

In the FDA's words

Description
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-CAE-14.0-83-EXTU, UDI (01)00827002240735(17)270509(10)16010654, Lot Number 16010654. Distribution: Worldwide distribution. Affected quantity: 95 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