WhichRecall
Class IIReported 2025-12-31

Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Recalled by Cook Incorporated

Reason for Recall

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification

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Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Recall Number
Z-0994-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-26
Reported
2025-12-31
Distribution
Worldwide distribution.
Code Info
1) Reference Part Number RTPS-100: Order Number G06541, UDI (01)00827002065413(17)280722(10)16705779, Lot Number 16705779; 2) Reference Part Number RTPS-100-10.0: Order Number G29769, UDI (01)00827002297692(17)280624(10)16659044, Lot Number 16659044
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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