The Recall Desk
HighFDA (Devices)·Z-1166-2015·Announced 2015-03-04

Navilyst Medical Recalls NAMIC Left Heart Cath Kits Due to Sterility Concerns

Navilyst Medical is recalling 62 units of NAMIC Left Heart Cath Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.

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 (infection risk due to potential sterility breach) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Navilyst Medical, Inc. is recalling 62 units of NAMIC Convenience Kits, specifically the Left Heart Cath Kit (REF/Catalog No. 601001815). The affected lots are 4361877, 4362670, 4384555, 4475742, 4534905, 4534906, 4572742, 4573424, 4603617, 4613738, 4623233, 4641655, 4642470, 4649930, 4654858, 4662098, 4666862, 4667793, 4672390, 4680972, 4681793, 4690126, 4696307, 4702956, 4706317, 4716358, 4726251, 4736913, 4747725, 4766391, 4778794, 4816062, 4820335, 4824146, and 4834213.

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.

The affected products were distributed worldwide, including the United States, Canada, and Guam. These devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems and are for single use only. Healthcare providers and facilities should check their inventory for the specific lot numbers listed above and stop using any affected units.

The recalled product

Product
NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, 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 — Catheter Kits
Hazard
Affected units
62

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 4361877
  • 4362670
  • 4384555
  • 4475742
  • 4534905
  • 4534906
  • 4572742
  • 4573424
  • 4603617
  • 4613738
  • 4623233
  • 4641655
  • 4642470
  • 4649930
  • 4654858
  • 4662098
  • 4666862
  • 4667793
  • 4672390
  • 4680972

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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