FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0995-2026
·
Reported December 31, 2025
Enforcement
- Recall Number
- Z-0995-2026
- Event ID
- 98027
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2025
- Initiation Date
- November 26, 2025
- Classification Date
- December 23, 2025
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
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
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 Info
Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065
Distribution
Worldwide distribution.
Quantity
23 units