Moderate riskFDA DeviceClass II

Cook Medical multipurpose drainage catheter recalled for incorrect expiration dates

Cook Medical multipurpose drainage catheters from two specific lots were labeled with expiration dates that go beyond their actual safe shelf life. This means catheters could be used after they are no longer guaranteed to be sterile or safe. The affected catheters were distributed worldwide, and 20 units are involved.

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

What to do

  1. Check if you have a Cook Medical multipurpose drainage catheter with lot number NS15690755 or NS15408335
  2. Do not use these catheters if you have them
  3. Contact Cook Medical or your healthcare provider for a replacement

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 18 products — see all of them.

Details

Units affected
20 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1786-2026

In the FDA's words

Description
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335. Distribution: Worldwide distribution. Affected quantity: 20 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

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Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device