Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps

FDA device recall Z-2263-2024 · posted 2024-07-03 · Open, Classified

Recall details

Recalling firm

Zyno Medical LLC

Reason for recall

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.

Action taken

An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/4/24 was sent to customers. Recommended Actions When using a system that has been identified as having the power supply module issue, keep them plugged into an external AC mains power source. 1. Actions to Address the Issue During Use Operate the unit on AC mains power source. If the affected system is disconnected from the external AC mains power source and the system presents an audible low battery alarm, re-connect the system to the external AC mains power source. If the affected system is disconnected from the external AC mains power source and immediately shuts down, re-connect to the external AC mains power source, and re-start the infusion therapy. If the system is turned on and it presents an audible low battery alarm prior to initiation of infusion therapy, proceed to a different system for the planned infusion therapy. Note that only the devices listed in this letter are affected. No other products are involved in this action. 2. Actions to Correct the Issue Complete the attached Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pump Power Supply Module Issue Response Verification Form. This will include checking your inventory for the affected products, verifying serial numbers, confirming product location, reporting any transferred product, and signing and dating the completed form. 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. Pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location. If you have any questions or would like assistance, please contact your local Business Development Manager. OTHER INFORMATION: " feedback@intuvie.com

Root cause

Process control

Status

Open, Classified

Product code

FRN

Quantity affected

88 units

Distribution

US Nationwide distribution.

Date initiated

2024-06-04

Date posted

2024-07-03

Location

Natick, MA

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