Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 390 NAMIC Convenience 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 (sterility breach leading to infection risk) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Navilyst Medical, Inc. is recalling 390 units of NAMIC Convenience Kits (REF/Catalog No. 60130834). These sterile, single-use devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall is due to the fact that the labeled 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 were distributed worldwide, including the United States, Canada, and Guam.
Consumers and healthcare providers should stop using the affected lots immediately and contact Navilyst Medical for further instructions. The specific lot numbers affected are listed in the recall documentation.
The recalled product
- Product
- NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, 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
- 390
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 4249145
- 4254175
- 4268512
- 4284473
- 4310130
- 4344873
- 4384704
- 4397287
- 4413719
- 4416032
- 4436682
- 4438637
- 4447642
- 4447643
- 4448692
- 4474988
- 4477699
- 4504970
- 4507585
- 4548216
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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See all →- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst NAMIC Convenience Kits Recalled for Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
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