Zyno Medical LLC: Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The 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 physician or other certified healthcare professional.

Recall number

Z-0523-2025

Recalling firm

Zyno Medical LLC

Product

Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The 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 physician or other certified healthcare professional.

Status

Open, Classified

Initiated

2024-09-30

Posted

2024-11-22

Terminated

not on file

Reason

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Root cause

Software design (manufacturing process)

Action

On September 30, 2024 MEDICAL DEVICE NOTIFICATION letters were sent to customers. Mitigation: Zyno Medical is issuing this customer notification, advising customers that the expected User ID may be missing from completed therapies in the EMR Patient Record. Zyno Medical is planning to correct this issue through an update to the software. Recommended Actions: The user can locate the Patient Order in the Patient Record in the EMR and manually update the record to reflect the administrating clinician s User ID until the Z-800WF pump software version is updated. Follow the guidelines of your facility for performing manual updates in the EMR. Reporting Adverse Events: We strongly encourage healthcare providers and patients to promptly report any adverse events associated with the use of the Zyno Medical Z-800, Z-800F, Z-800W, and/or Z-800WF Infusion Pump. Please send your reports to Zyno Medical via email to feedback@intuvie.com. Additionally, we urge you to report any negative side effects related to the Zyno Medical Z-800, Z-800F, Z-800W, and/or Z-800WF Infusion Pumps to the FDA. You can submit your report online at www.fda.gov/medwatch or by calling 1-800-FDA-1088. Your cooperation in reporting these events is vital for continuous safety monitoring of medical devices. For information about the Zyno Medical Z-800, Z-800F, Z-800W, and/or Z-800WF Infusion Pumps, including benefits and risks, refer to the Zyno Medical Z-800 Infusion Pump Instructions for Use (Z-800 800-IFU-6651, Z-800F 800-IFU-2602, Z-800W 800W-IFU-3614, and Z-800WF 800WF-IFU-4602) for complete description of the benefits and risks of using the Zyno Medical Z-800 family of pumps. Zyno Medical is committed to offering products which meet the highest quality standards and to continuous improvement in the interest of patient safety. We regret any inconvenience that this action may cause, but believe transparent communication will ensure you have timely, relevant information for managing your patients. If you

Quantity

100 units

Distribution

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

Lot, serial or model codes

Model/Catalog Number: Z-800WF; UDI-DI: 00814371020006; Serial Numbers: 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500356, 500357, 500358, 500359, 500360, 500361, 500362, 500363, 500364, 500365, 500367, 500368, 500369, 500370, 500371, 500373, 500374, 500375, 500376, 500377, 500378, 500384, 500385, 500386, 500388, 500389, 500390, 500391, 500392, 500393, 500394, 502634, 503435, 503716, 503799, 503917, 503921, 504534, 504807, 504808, 504809, 504810, 504811, 504812, 504813, 504814, 504815, 504816, 504817, 504818, 504819, 504820, 504821, 504822, 504823, 504824, 504825, 504826, 504827, 504828, 504829, 504830, 504831, 504832, 504834, 504835, 504836, 504838, 505369, 505425, 505430, 505432, 505437, 505626, 505627, 505628, 505629, 505630, 505631, 505632, 505633, 505635, 505637, 505638, 505691, 505692, 505693, 506585, 506982, 506983.

510(k) numbers

["K130690","K100705"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3006575795

Firm city

Natick

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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