FDA-Device2026-04-15Class II

COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

Cook Incorporated

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

Original summary

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

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