Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Affected Serial Numbers for Z-800 (UDI-DI: 00814377102006)

800242	801925	802867	900875	901058	901089
901101	901126	901143	901567	904021	904073
800378	801950	803020	900914	901061	901090
901102	901129	901145	901795	904023	904083
801082	802113	803268	900961	901066	901091
901103	901130	901230	904004	904026	904087
801353	802131	803526	900964	901070	901092
901110	901131	901240	904006	904027	904093
801420	802160	803768	901001	901076	901093
901112	901132	901241	904007	904028	904094
801503	802645	900029	901014	901077	901094
901113	901133	901244	904009	904029	905077
801601	802753	900035	901024	901081	901095
901115	901134	901245	904011	904030	905162
801640	802764	900051	901041	901083	901096
901116	901136	901246	904012	904031	906681
801852	802771	900115	901054	901085	901097
901117	901138	901249	904013	904038	906692
801855	802774	900133	901055	901086	901098
901118	901140	901250	904014	904040	906693
801881	802780	900147	901056	901087	901099
901119	901141	901252	904018	904042	906716
801884	802798	900569	901057	901088	901100
901123	901142	901255	904020	904053	906720
906721

Affected Serial Numbers for Z-800F (UDI-DI: 00814371020013)

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	600615
600111	600154	600228	600294	600338	600385
600419	600461	600505	600543	600578	600617
600112	600155	600229	600295	600339	600386
600422	600462	600506	600545	600579	600618
600113	600156	600230	600297	600341	600387
600423	600464	600509	600546	600580	600921
600114	600157	600231	600298	600342	600388
600424	600465	600510	600549	600583	601325
600115	600158	600235	600299	600343	600389
600425	600466	600511	600551	600584	601433
600116	600159	600238	600300	600344	600391
600427	600467	600513	600553	600585	601514
600118	600160	600239	600301	600347	600392
600430	600470	600514	600554	600586	601603
600120	600161	600240	600302	600348	600393
600431	600471	600516	600555	600587	601651
600121	600162	600249	600303	600349	600394
600432	600473	600517	600556	600589	602578
600122	600164	600250	600304	600350	600396
600436	600474	600518	600557	600591	602743
600126	600165	600251	600305	600351	600398
600437	600475	600519	600558	600592	602807
600127	600168	600252	600306	600352	600399
600438	600476	600520	600559	600594	603858
600129	600174	600253	600308	600353	600400
600440	600477	600521	600560	600595	604637
600130	600176	600254	600309	600356	600401
600442	600478	600522	600562	600596	605411
600131	600188	600255	600310	600357	600402
600443	600480	600523	600563	600599	605870
600132	600192	600257	600319	600359	600403
600445	600481	600525	600564	600600	605918
605964	606886	607077	607891	608058	608061
608612	613123	614776

Affected Serial Numbers for Z-800W (UDI-DI: 00814371020020)

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

Affected Serial Numbers for Z-800WF (UDI-DI: 00814371020037)

500004	500005	500006	500810	500812	500813
501748	503680	503681	503682

What to Do

On May 7, 2025 Zyno Medical sent all affected customers an email recommending the following actions:

Discontinue use of affected devices and follow instructions for the return of the device.
Check inventory for affected products, verify serial numbers, and confirm product location.
Report any transferred product and pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location.
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.

Reason for Recall

Zyno Medical stated that certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps were released to customers with incorrect software versions that had not undergone required verification and validation testing. As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.

The worst case scenarios of incorrect air in line detection and incorrect audio alarms associated with other failures could result in serious harms such as under- or over-delivery of drugs, air in line that infuses a venous air embolism of up to 1mL, undetected flow reversal of drugs or parenteral fluids, and lowering of the Keep Vein Open (KVO) rate from 5 mL/hr to 1 mL/hr, which can lead to very low KVO flow rates and possibly cause a blood clot to form at the distal end of the catheter, ultimately leading to peripheral IV catheter (PIV) failure.

At this time, Zyno Medical has not reported any serious injuries or deaths.

Device Use

The Zyno Medical Z-800 Infusion System is intended to provide intravenous infusion of
parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Zyno Medical at feedback@intuvie.com or 508-650-2008.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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