The Recall Desk
HighFDA (Devices)·Z-2895-2016·Announced 2016-10-05

Zyno Medical Administration Set Recalled for Potential Filter Leaking

Zyno Medical LLC is recalling 78,063 sterile administration sets due to a potential filter leaking defect. The sets are distributed nationwide for use with infusion pumps or gravity feed.

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, and the source text does not report any illnesses or injuries, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zyno Medical LLC is recalling 78,063 units of the Zyno Medical Administration Set, Sterile. The affected product codes are B2-70071-DF and B2-70071-DF-120. These devices are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein, and are intended for use with Zyno Medical Infusion Pumps or gravity feed.

The recall is being issued because of a potential filter leaking defect. The agency has classified this as a Class II recall. The affected lots were distributed nationwide in the United States.

Healthcare providers and consumers should stop using the affected administration sets immediately. Specific lot codes for the B2-70071-DF product include 14015279, 14026620, 14046841, 14055191, 14055786, 14056225, 14085743, 14085742, 15035297, 15045941, 15045940, 15046600, 15075275, 15075835, 15076761, 15085107, 15086621, 15095200, 15095647, 15097179, and 15105595. Specific lot codes for the B2-70071-DF-120 product include 15066912, 15075253, 15075990, 15076261, and 15076304.

The recalled product

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 conta
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion / Administration Sets
Hazard
Affected units
78,063

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 →

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