Recall Z-1024-2013— Zyno Medical LLC

Name: FDA recall Z-1024-2013
Creator: U.S. Food and Drug Administration
Published: 2011-06-13

Class II · Terminated

Class II FDA medical device recall by Zyno Medical LLC, initiated 2011-06-13, terminated 2016-07-25. It names 2 FDA 510(k) clearances: K100705, K071545. Product: Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.. Reason: Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump.

Recalling firm: Zyno Medical LLC
Classification: Class II
Status: Terminated
Initiated: 2011-06-13
Terminated: 2016-07-25
Firm location: Natick, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800Zyno Medical, LLC·cleared 2010-07-08
K071545 — Z-800 VOLUMETRIC INFUSION PUMPZyno Medical, LLC·cleared 2007-10-31

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

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

Reason for recall

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

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