Cook Incorporated recalled 20 units of its Multipurpose Drainage Catheter reference ULT8.5-38-25-P-CLMS-8-RH-FS distributed worldwide. The recall cites expiration dates that exceed the product’s true shelf life. Healthcare providers and patients should stop using the affected devices immediately.
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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This is a medical device used in drainage procedures. It is intended for hospital use and tangibly affects patient care.
Labeling that overstates shelf life could lead to using expired devices, compromising sterility or effectiveness.
This recall is not indicated as part of a broader industry pattern.
The recall centers on labeling accuracy rather than device performance. Hospitals must verify lot numbers and expiry dates to prevent usage of potentially expired devices.
FDA recall page and Cook Incorporated communications
Remedies are determined by Cook Incorporated; processing time varies by institution
Maintain recall notice, purchase records, and disposition documentation
Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS. Order Number G29775. Quantity: 20 units. Distribution: Worldwide. Recall date: 2026-03-05. Status: ACTIVE.
No specific injuries or incidents are reported in the provided data.
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