Zyno Medical LLC: Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Hazard

Unreleased software versions were installed on distributed devices without verification or validation.

Details from the source

Reason for recall: Unreleased software versions were installed on distributed devices without verification or validation. Distribution: US Nationwide Quantity: 613 units Lot/code info: Model Number: Z800W; UDI-DI; 00814371020020; Serial No. 700063; 700163; 700203; 700402; 700488; 700093; 700169; 700210; 700428; 700495; 700104; 700172; 700214; 700431; 700503; 700111; 700188; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.

UPC codes

00814371020020

Source

Official record: FDA (Device enforcement) ↗

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