FDA-Device2025-12-31Class IIPROCESSING DEFECT
Cook Rösch-Uchida Transjugular Liver Access Sets recalled for manufacturing defects
OTHERNationwide distribution
Contact Cook Medical about liver access device
Cook Medical recalled Rösch-Uchida Transjugular Liver Access Sets (part number RUPS-100) used in liver procedures because some units were manufactured incorrectly. Affected devices may have been cut to the wrong length, not properly trimmed, or not inspected. Only 23 units were affected worldwide.
- If your facility received this device, check the lot number 16659065 against your inventory
- Contact Cook Medical immediately if you have affected units
- Do not use devices from the recalled lot for procedures
Hazard
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.
Sold states
Worldwide distribution.
Affected count
23 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2026More Cook Incorporated recalls
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