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Recall Observatory FDA recall evidence

Device product

R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Z-0995-2026

November 26, 2025

Class II

Product summary

Firm
Cook Incorporated
Event
Event 98027
Status
Ongoing
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-0995-2026

Official wording

Reason: 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.

Code information: Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification