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
Product summary
- 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
out of specification