Zyno Medical LLC.
Natick, MA, US
Zyno Medical LLC. appears in FDA device records in Natick, MA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Zyno Medical LLC. between 2007 and 2016. The busiest year on record is 2014, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) | FRN | Substantially Equivalent | |
| K140783 | HALO AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | |
| K132841 | ZYNO MEDICAL ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K130690 | Z-800 INFUSION SYSTEM | FRN | Substantially Equivalent | |
| K120685 | ZYNO MEDICAL ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 | FRN | Substantially Equivalent | |
| K071545 | Z-800 VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006575795 | 3006575795 | Zyno Medical LLC. | 177 Pine St, Natick, MA 01760 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1868-2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. | Unreleased software versions were installed on distributed devices without verification or validation. | Class I | Open, Classified | |
| Z-1867-2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. | Unreleased software versions were installed on distributed devices without verification or validation. | Class I | Open, Classified | |
| Z-1866-2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. | Unreleased software versions were installed on distributed devices without verification or validation. | Class I | Open, Classified | |
| Z-1865-2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. | Unreleased software versions were installed on distributed devices without verification or validation. | Class I | Open, Classified | |
| Z-0506-2025 | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, 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 of a physician or other certified healthcare professional. | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. | Class II | Open, Classified | |
| Z-0523-2025 | 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. | 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. | Class III | Open, Classified | |
| Z-0005-2025 | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z | There is a defect in the air-in-line software algorithm. | Class I | Open, Classified | |
| Z-2263-2024 | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power. | Class II | Open, Classified | |
| Z-1183-2024 | 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 | 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 | Class II | Open, Classified | |
| Z-2059-2019 | Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified | Class II | Terminated | |
| Z-2058-2019 | Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072 | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified | Class II | Terminated | |
| Z-2896-2016 | Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein. | Administration Set potential filter leaking | Class II | Terminated | |
| Z-2895-2016 | Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein. | Administration Set potential filter leaking | Class II | Terminated | |
| Z-2894-2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein. | Administration Set potential filter leaking | Class II | Terminated | |
| Z-2893-2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein. | Administration Set potential filter leaking | Class II | Terminated | |
| Z-1024-2013 | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain