Recall Z-2263-2024— Zyno Medical LLC

Name: FDA recall Z-2263-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-04

Class II · Ongoing

Class II FDA medical device recall by Zyno Medical LLC, initiated 2024-06-04. It names one FDA 510(k) clearance: K130690. Product: Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps. Reason: 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..

Recalling firm: Zyno Medical LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-06-04
Firm location: Natick, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K130690 — Z-800 INFUSION SYSTEMZyno Medical, LLC·cleared 2013-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.