Recall Z-1866-2025

Zyno Medical LLC · initiated May 7, 2025

Class I Open, Classified

Class I – dangerous or defective products that could cause serious health problems or death

Product

Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Codes / lots: Model No: Z800F; UDI-DI: 00814371020013; Serial No. 600091; 600133; 600203; 600259; 600320; 600361; 600404; 600446; 600482; 600526; 600565; 600601; 600094; 600138; 600204; 600261; 600321; 600362; 600406; 600447; 600483; 600528; 600566; 600603; 600095; 600139; 600206; 600262; 600322; 600363; 600407; 600449; 600485; 600529; 600568; 600604; 600099; 600141; 600207; 600263; 600323; 600364; 600408; 600450; 600487; 600531; 600569; 600605; 600100; 600142; 600209; 600265; 600324; 600369; 600410; 600451; 600488; 600532; 600570; 600608; 600102; 600143; 600211; 600266; 600325; 600370; 600411; 600452; 600489; 600533; 600571; 600609; 600104; 600146; 600215; 600267; 600326; 600376; 600412; 600453; 600490; 600535; 600572; 600610; 600105; 600148; 600217; 600268; 600328; 600377; 600414; 600454; 600495 600536; 600573; 600611; 600106; 600150; 600220; 600270; 600330; 600378; 600415; 600456; 600496; 600539; 600574; 600612; 600108; 600151; 600223; 600271; 600331; 600379; 600416; 600457; 600498; 600540; 600575; 600613; 600109; 600152; 600224; 600289; 600335; 600383; 600417; 600458; 600499; 600541; 600576; 600614; 600110; 600153; 600227; 600292; 600336; 600384; 600418; 600460; 600504; 600542; 600577…

Reason for recall

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

FDA-determined cause: Software design (manufacturing process)

Action taken

Consignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at feedback@intuvie.com. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.

Details

Recall number
Z-1866-2025
Initiated
May 7, 2025
Posted by FDA
June 6, 2025
Product code
FRN – Pump, Infusion
Quantity
613 units
Distribution
US Nationwide
Recalling firm
Zyno Medical LLC, Natick, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1865-2025 Class IZ-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. 05/07/2025Open, Classified
Z-1867-2025 Class IZ-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. 05/07/2025Open, Classified
Z-1868-2025 Class IZ-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. 05/07/2025Open, Classified