CLASS II Device recall · Reported 10 Apr 2013 · FDA Enforcement Report

Z-800 Volumetric Infusion System recalled by Zyno Medical

Zyno Medical is recalling Z-800 Volumetric Infusion System, distributed nationwide in the US. The recall was initiated on 13 Jun 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH

Quantity recalled2589 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1024-2013
FDA event ID: 64448
Recalling firm: Zyno Medical, Natick, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jun 2011
FDA classified: 29 Mar 2013
Reported: 10 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Jun 2011	Recall initiated by company
29 Mar 2013	Classified by FDA	+655 days
10 Apr 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

Which lots are affected?

LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zyno Medical

All 16

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025Device	CLASS I	Z-800F Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800W Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800WF Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Z-800 Infusion System Z-800WF recalled by Zyno Medical	Zyno Medical	Device Malfunction	8 states

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