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Cook Incorporated: R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended

Medical DevicesSource: FDA (device) · Date: 2025-12-31

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Cook Incorporated
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 / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution.
Recall initiated
2025-11-26
Code info
Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065
Product quantity
23 units
Voluntary mandated
Voluntary: Firm initiated
City
Bloomington
State
IN
Country
United States
Event id
98027
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