Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 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 NAMIC Convenience Kits (UPN H749601399921, REF/Catalog No. 60139992) due to concerns regarding the product's expiration dating. The labelled expiration dating of the affected product is not fully supported by shelf life verification testing. This deficiency may result in a sterility breach.
The affected product is a sterile, single-use device intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall includes Lot 4500974. The product was distributed worldwide, including the United States, Canada, and Guam.
Use of a Fluid Management Convenience Kit where sterility has been breached may result in an increased risk of infection. The source text does not specify the number of affected units or report any specific illnesses or injuries. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, 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
- Affected units
- 1
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 (1)
- Lot 4500974
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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