Agency classClass IIOur severity:High FDA (Devices)·Z-1172-2015·Announced 2015-03-04

Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

Navilyst Medical is recalling 10 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 risk-of-harm product (sterility breach leading to infection) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Navilyst Medical, Inc. is recalling 10 units of NAMIC Convenience Kits, ANGIO KIT, REF/Catalog No. 60131996. The affected lots are 4426279, 4500022, 4519371, 4637654, and 4651033. These sterile, prescription-only devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems.

The recall was initiated because the labeled expiration dating of the affected product is not fully supported by shelf life verification testing. This lack of support may result in a sterility breach. Use of a Fluid Management Convenience Kit where sterility has been breached may result in an increased risk of infection.

The affected products were distributed worldwide, including the United States, Canada, and Guam. Healthcare facilities and consumers should stop using the affected lots and contact Navilyst Medical for further instructions.

The recalled product

Product: NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring…
Manufacturer: Navilyst Medical, Inc
Category: Medical Device — Fluid Management
Hazard: infection
sterility-breach
Affected units: 10

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 (5)

Lots 4426279
4500022
4519371
4637654
4651033.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 60 recalled by Navilyst Medical, Inc 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 60 products in this recall →

Same manufacturer · Navilyst Medical, Inc

See all →

High
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
High
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
High
Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns
FDA (Devices) · 2015-03-04
High
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
High
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04

Same hazard · infection