The Recall Desk
HighFDA (Devices)·Z-1853-2017·Announced 2017-04-26

NAMIC Fluid Delivery Set Recalled for Potential Non-Sterility

Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.

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 with a potential sterility failure, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 8 boxes containing 25 units of the NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005. The recall involves Lot Number 5122528.

The recall was initiated because the product has the potential to be non-sterile, as it was not packaged in accordance with specification. This defect could compromise the sterility of the medical device.

The affected units were distributed to facilities in California, Kentucky, Maryland, Oregon, Virginia, and Texas. Users should stop using the product and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 5122528

Distribution

Distributed in 6 states:

Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)

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