The Recall Desk
HighFDA (Devices)·Z-2896-2016·Announced 2016-10-05

Zyno Medical Administration Set Recalled for Potential Filter Leaking

Zyno Medical LLC is recalling 47,989 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients.

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 involves a medical device used for vascular administration with a defect that could compromise sterility or fluid integrity. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zyno Medical LLC is recalling 47,989 units of the Zyno Medical Administration Set Sterile. The product is a prescription device used to administer fluids from a container to a patient's vascular system through a needle or catheter. The recall is due to a potential defect where the filter may leak.

The affected product code is B2-70072-F. The recall covers specific lot codes including 14015368, 14056014, 14056664, 14105490, 14106247, 14115294, 15035318, 15046218, 15065675, 15066275, 15095552, 15097055, and 15105046. The product was distributed nationwide in the United States.

Healthcare providers and consumers should check their inventory for the affected lot codes. If the product is found, it should be removed from use and returned to Zyno Medical LLC for credit or replacement.

The recalled product

Product
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion Pumps and Administration Sets
Hazard
Affected units
47,989

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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