Recall Z-1183-2024— Zyno Medical LLC

Name: FDA recall Z-1183-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Class II · Ongoing

Class II FDA medical device recall by Zyno Medical LLC, initiated 2023-12-20. It names one FDA 510(k) clearance: K130690. Product: Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF. Reason: 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 therapy and in extreme cases, associated risk of organ failure or death.

Recalling firm: Zyno Medical LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-12-20
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 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

Reason for recall

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 therapy and in extreme cases, associated risk of organ failure or death

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