Cook Medical recalled 23 units of its Transjugular Liver Access Sets on November 26, 2025. The recall follows concerns that products may have been manufactured out of specification, leading to potential use errors. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
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: Letter
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The R¿sch-Uchida Transjugular Liver Access Set is a medical device used for gaining access to the liver for diagnostic and interventional procedures. Healthcare providers use it in various liver-related treatments, making it essential for patient care.
The manufacturing defects may result in the device being cut to the wrong length or improperly trimmed, increasing the risk of complications during procedures. Proper device specifications are critical for safe medical interventions.
This recall is not part of a broader industry pattern.
This recall may cause inconvenience for healthcare providers, necessitating the procurement of alternative devices. There is a heightened urgency for patient safety in medical procedures involving the liver.
The part number and lot number can usually be found on the packaging or the device itself, often near the barcode.
Expect a timeline of about 4-6 weeks for refund or replacement processing after returning the affected device.
Keep copies of receipts, any communication related to the recall, and product identification details for your records.
The affected product is the R¿sch-Uchida Transjugular Liver Access Set, Reference Part Number RUPS-100. It was distributed worldwide. The order number is G06929, and the UDI is (01)00827002069299(17)280624(10)16659065.
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