The Recall Desk
HighFDA (Devices)·Z-1153-2015·Announced 2015-03-04

Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

Navilyst Medical is recalling 136 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

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

Plain-English summary

Navilyst Medical, Inc. is recalling 136 units of NAMIC Convenience Kits (REF/Catalog No. 60032942). 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 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.

Healthcare providers and facilities should stop using the affected lots immediately. The specific lot numbers involved are: 4244953, 4269320, 4384561, 4394016, 4416958, 4437380, 4442476, 4447489, 4475748, 4504884, 4508759, 4535420, 4603968, 4612720, 4622798, 4623909, 4641674, 4641675, 4654862, 4662506, 4666610, 4672626, 4672627, 4690446, and 4697032.

The recalled product

Product
NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, 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 Monitoring Systems.
Manufacturer
Navilyst Medical, Inc
Category
Medical Device — Fluid Management
Hazard
Affected units
136

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 4244953
  • 4269320
  • 4384561
  • 4394016
  • 4416958
  • 4437380
  • 4442476
  • 4447489
  • 4475748
  • 4504884
  • 4508759
  • 4535420
  • 4603968
  • 4612720
  • 4622798
  • 4623909
  • 4641674
  • 4641675
  • 4654862
  • 4662506

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 →

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