The Recall Desk
HighFDA (Devices)·Z-2893-2016·Announced 2016-10-05

Zyno Medical Administration Set Recalled for Potential Filter Leaking

Zyno Medical LLC is recalling 114,081 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients' vascular systems.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).

Plain-English summary

Zyno Medical LLC is recalling 114,081 units of the Zyno Medical Administration Set, Sterile. These prescription devices are used to administer fluids from a container to a patient's vascular system through a needle or catheter. The recall covers Product Codes A2-80071-DF and A2-80071-DF-120, distributed nationwide in the United States.

The recall was initiated because the administration sets have a potential filter leaking defect. The FDA has classified this as a Class II recall, indicating a situation that could temporarily cause or present a slight probability of serious adverse health consequences.

Healthcare providers and facilities that have purchased these specific product codes and lot numbers should stop using the affected sets. Consumers should contact Zyno Medical LLC for further instructions on how to proceed with the recall.

The recalled product

Product
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 contai
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion / Administration Sets
Hazard
Affected units
114,081

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Zyno Medical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Zyno Medical LLC

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Same hazard · filter leak

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