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Recall Observatory FDA recall evidence

Device product

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

Z-1784-2026

March 05, 2026

Class II

Product summary

Firm
Cook Incorporated
Event
Event 98495
Status
Ongoing
Classification
Class II
Quantity
49 units
Official record key
device-enforcement:Z-1784-2026

Official wording

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

Code information: 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 pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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