Recall Z-2895-2016— Zyno Medical LLC

Name: FDA recall Z-2895-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-29

Class II · Terminated

Class II FDA medical device recall by Zyno Medical LLC, initiated 2016-07-29, terminated 2017-07-11. It names one FDA 510(k) clearance: K132841. Product: Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.. Reason: Administration Set potential filter leaking.

Recalling firm: Zyno Medical LLC
Classification: Class II
Status: Terminated
Initiated: 2016-07-29
Terminated: 2017-07-11
Firm location: Natick, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K132841 — ZYNO MEDICAL ADMINISTRATION SETZyno Medical, LLC·cleared 2014-01-23

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 Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.

Reason for recall

Administration Set potential filter leaking

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