FDA-Device2026-04-15Class IIMISBRANDING

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

EXPIRATION DATE ERRORNationwide distribution

Check Cook Medical bile duct exploration kit expiration

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.

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

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Sold states
Worldwide distribution.
Affected count
49 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1784-2026

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