Medical device recalls Moderate risk

Zyno Medical LLC recalls Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-…

Recall date
July 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2893-2016
FDA classification
Class II
Brand / firm
Zyno Medical LLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

Administration Set potential filter leaking

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-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.

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