Cook Medical recalled 49 units of the Approach CTO-12 Micro Wire Guide due to expiration dates that exceed the true shelf life. The recall covers two reference part numbers and multiple lots distributed worldwide. Healthcare providers and patients should stop using the affected devices immediately. Follow the manufacturer’s recall instructions or contact a healthcare provider for guidance.
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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Cook Medical Approach CTO-12 Micro Wire Guide is a device used in complex vascular procedures to steer catheters.
Incorrect expiration labeling could imply compromised shelf life, potentially affecting sterility or performance.
This recall is not clearly stated as part of a broader industry pattern.
No injuries reported yet; potential impact includes need for verification and possible device replacement in clinical settings.
FDA recall page linked in recall notice and Cook Medical customer service
Replacement/refund process to follow Cook recall instructions, typically weeks to months
Keep recall notice, batch/lot numbers, purchase records, and any correspondence with Cook or healthcare providers
Product: Cook Medical Approach CTO-12 Micro Wire Guide. Reference Part Numbers: CMW-14-190-12G (Order Number G50787) and CMW-14-300-12G (Order Number G50791). Distribution: Worldwide. Recall date: 2026-03-05. Quantity: 49 units. Classification: Class II.
No specific injuries or incidents are described in the provided information.
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