Agency classClass IIOur severity:High FDA (Devices)·Z-1158-2015·Announced 2015-03-04

Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns

Navilyst Medical is recalling 454 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

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 is classified as FDA Class II and involves a risk of infection due to potential sterility breach, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Navilyst Medical, Inc. is recalling 454 units of NAMIC Convenience Kits, specifically the LEFT HEART KIT (REF/Catalog No. 600500113). These sterile, single-use devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall is classified as Class II by the FDA.

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

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

The recalled product

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
Manufacturer: Navilyst Medical, Inc
Category: Medical Device — Fluid Management
Hazard: infection
sterility-breach
Affected units: 454

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 (20)

Lots 4247589
4269253
4271313
4310122
4342473
4344822
4387486
4388838
4414801
4419289
4437439
4447579
4474969
4491873
4504923
4534887
4534888
4572805
4604160
4612239

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 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 Kit Recalled for Potential Sterility Breach
FDA (Devices) · 2015-03-04

Same hazard · infection