The Recall Desk
HighFDA (Devices)·Z-1203-2015·Announced 2015-03-04

Navilyst NAMIC Convenience Kit Recalled for Potential Sterility Breach

Navilyst Medical is recalling 20 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

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, fitting the High severity criteria.

Plain-English summary

Navilyst Medical, Inc. is recalling 20 units of the NAMIC Convenience Kit (REF/Catalog No. 60195541). The product is a sterile, single-use device intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall is due to the fact that the labelled expiration dating of the affected product is not fully supported by shelf life verification testing.

The lack of full support for the expiration dating 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 lots are 4361732, 4445198, 4512179, 4596980, 4608449, 4657491, 4671286, 4699834, 4742947, 4764114, 4772460, 4806954, and 4812145.

The product was distributed worldwide, including the United States, Canada, and Guam. Healthcare providers and facilities should check their inventory for the specific lot numbers listed and stop using the affected products. Consumers should not use the recalled kits and should contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. 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
20

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 (13)

  • Lots 4361732
  • 4445198
  • 4512179
  • 4596980
  • 4608449
  • 4657491
  • 4671286
  • 4699834
  • 4742947
  • 4764114
  • 4772460
  • 4806954
  • 4812145.

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 →

Related recalls

Same manufacturer · Navilyst Medical, Inc

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Same hazard · sterility breach

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