FDA recall Z-2263-2024

Zyno Medical LLC · Class II · device

Product

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

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-06-04
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2263-2024