Cook Medical recalled 49 units of the Strange Bile Duct Stone Exploration Set due to labels showing expiration dates beyond shelf life. The recall is worldwide and active as of March 5, 2026. Healthcare providers were advised to stop use and follow recall instructions.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The Cook Strange Bile Duct Stone Exploration Set is a surgical instrument used in biliary procedures. It helps explore stones in the bile ducts.
Expiration labeling beyond shelf life could affect sterility or instrument performance, risking infection or procedure failure.
This recall is not part of a broader industry pattern.
Direct impact on clinical procedures and patient safety; potential delays and need for device recalls in operating rooms.
FDA recall page and Cook Medical recall communications
Refunds/replacements processed per Cook Medical protocol, typically weeks to months
Keep recall notices, batch/lot numbers, purchase records, and correspondence
Model: Reference Part Number C-CSRC-7.5D-40-STRANGE. UDI: 01 00827002091085 17 260221 10 15133690X and other UDIs for lot numbers 15133690X, 15274382, 15435573, 15445615, 15501690. Order Number G09108. Quantity: 49 units. Distribution: Worldwide.
No specific injuries or incidents are described in the recall notice.
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