Z-1183-2024Class II

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids...

Name: Z-1183-2024 Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids...
Creator: Zyno Medical LLC
Published: 2023-12-20
License: https://open.fda.gov/license/

Zyno Medical LLC. / initiated 2023-12-20 / Open, Classified / root cause: software

FDA source

Zyno Medical LLC began a recall of Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the... on 2023-12-20. FDA classified it as Class II and gives the reason as "When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1183-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-20
Posted: 2024-02-23
Recalling firm: Zyno Medical LLC.
Product: Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Product code: FRN Pump, Infusion
Reason for recall: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Root cause tag: software
FDA root cause: Software design
Action: Zyno Medical LLC issued URGENT: Medical Device Correction Zyno Medical Z-800WF Infusion Pump -Alarm Volume Reversion Issue letter on 12/20/23 via Certified Mail. Letter states reason for recall, health risk and action to take: To address this issue, users can reset the alarm volume by accessing the Factory Settings (2) via the configuration menu on the pump and selecting the desired alarm volume. The chosen setting will remain on the pump until it is manually altered or until the initial workflow that triggered the reversion is repeated. Zyno Medical LLC is mitigating this alarm issue by conducting a voluntary medical device correction to downgrade the software from version 5.2.05 to version 5.1.87. Please note that the low volume alarm issue occurred with a specific software change that occurred in version 5.2.05 and the issue does not exist. Complete the attached Zyno Medical Z-800WF Infusion Pump - Alarm Volume Reversion Issue -Response Verification Form. This will include checking your inventory for affected products, verifying serial numbers, confirming product location, reporting any transferred product, and signing and dating the completed form. 3. A representative from Zyno Medical's distribution partner, lntuvie LLC, will be in contact with you to coordinate instructions on exchanging devices and the timing to remediate this action. 4. Pass this notice to the appropriate healthcare professional within your facility who needs to be informed and to any facility where the potentially affected devices have been transferred (if appropriate). Provide Zyno Medical with details of any affected devices that have been transferred to other facilities. If you have any questions or would like assistance, please contact your local Business Development Manager
Quantity in commerce: 574 units
Distribution: Nationwide
Product codes and lots: UDI: 00814371020037 software version 5.2.05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1183-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1183-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-23

Product code FRN

K130690Class IIZ-800 Infusion SystemZyno Medical, LLC / cleared 2013-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)