Cook Incorporated: 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

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.

Details from the source

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. Distribution: Worldwide distribution. Quantity: 23 units Lot/code info: Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065

UPC codes

00827002069299

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.