Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 10 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.
Plain-English summary
Navilyst Medical, Inc. is recalling 10 units of NAMIC Convenience Kits, ANGIO KIT, REF/Catalog No. 60131996. The affected lots are 4426279, 4500022, 4519371, 4637654, and 4651033. These sterile, prescription-only devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems.
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. 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. Healthcare facilities and consumers should stop using the affected lots and contact Navilyst Medical for further instructions.
The recalled product
- Product
- NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 10
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 (5)
- Lots 4426279
- 4500022
- 4519371
- 4637654
- 4651033.
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
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