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Moderate riskFDA DeviceClass II

Cook Medical Strange Bile Duct Stone Exploration Set recalled for incorrect expiration dates

Cook Medical's Strange Bile Duct Stone Exploration Set (model C-CSRC-7.5D-40-STRANGE) in five specific lot numbers has been labeled with expiration dates that are longer than the device's actual shelf life. This means the device may degrade or fail before the printed date suggests it should.

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

What to do

  1. Check your inventory for the five affected lot numbers (15133690X, 15274382, 15435573, 15445615, 15501690)
  2. Do not use devices from these lots beyond their true shelf life, which is earlier than the printed expiration date
  3. Contact Cook Medical for guidance on the correct expiration date for your lot
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Sold in
Nationwide
Made for
All ages (under 100 years)

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-1784-2026

In the FDA's words

Description
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260221(10)15133690X, Lot Number 15133690X; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260314(10)15274382, Lot Number 15274382; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270104(10)15435573, Lot Number 15435573; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270118(10)15445615, Lot Number 15445615; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270104(10)15501690, Lot Number 15501690. 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