Recall Z-0995-2026— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2025-11-26. It names one FDA 510(k) clearance: K171820. 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.. 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..
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-26
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.