Agency classClass IIOur severity:High FDA (Devices)·Z-1162-2015·Announced 2015-03-04

Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

Navilyst Medical is recalling 562 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 562 units of the NAMIC Convenience Kit, LEFT HEART KIT (UPN H749600618011, REF/Catalog No. 60061801). These sterile, single-use devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The affected lots were distributed nationwide in the United States, as well as in Canada and Guam.

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. The use of a Fluid Management Convenience Kit where sterility has been breached may result in an increased risk of infection.

Healthcare providers and facilities should stop using the affected lots immediately and contact Navilyst Medical for further instructions. Consumers should not use these devices if they have them in their possession.

The recalled product

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, 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: 562

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 4246299
4271288
4279323
4309482
4336779
4346494
4365250
4377114
4384505
4399088
4413662
4419628
4437368
4447518
4462779
4487773
4498391
4504948
4535392
4578775

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