Zyno Medical LLC recalls 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…
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Read the official notice →- Date
- 2024-11-27
- Country
- United States
- Brand
- Zyno Medical
- Product
- 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…
- Classification
- Class II
- Units
- This product is distributed only in the United States.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Zyno Medical recalls
- 2025-06-18
USZyno Medical LLC recalls 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.
- 2024-12-04
- US
Zyno Medical LLC recalls Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide…
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.
- 2024-10-16
- US
Zyno Medical LLC recalls 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…
There is a defect in the air-in-line software algorithm.
- 2024-07-10
- US
Zyno Medical LLC recalls 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…
- 2024-03-06
- US
Zyno Medical LLC recalls Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to…
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…
Other drugs & medical recalls in the United States
- 2024-12-04
- US
- US
Neogen Corporation recalls LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925…
CGMP violations.
FDA · DrugNeogen CorporationProduct sold directly to one distributor consignee, Bob Barker Company, an…Official notice → - US
- 2024-11-27
- US
OrganOx Ltd recalls OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx…
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
FDA · DeviceOrganOx LtdCalifornia, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma,…Official notice → - US
NuVasive Specialized Orthopedics, Inc. recalls Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX…
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
FDA · DeviceNuVasive Specialized Orthopedics, Inc.U.S distribution to states of: FL and NV.Official notice → - US
Cook Incorporated recalls Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Devices from the affected device lots have labels that state the incorrect expiration dates.