Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 64 units of 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 (sterile medical device) where a sterility breach could lead to infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Navilyst Medical, Inc. is recalling 64 units of NAMIC Convenience Kits (Catalog No. 60101491). These sterile, single-use kits are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The affected lots are 4268921, 4310402, 4317001, 4384580, 4442479, 4500790, 4504919, 4599070, 4645482, 4661978, 4680493, 4704381, 4742117, 4777180, and 4801317.
The recall was initiated because the labeled expiration dating of the affected product is not fully supported by shelf life verification testing. This deficiency 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. Healthcare facilities and consumers should stop using the affected lots and contact Navilyst Medical for further instructions.
The recalled product
- Product
- NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, 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 Monitori
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 64
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 (15)
- Lots 4268921
- 4310402
- 4317001
- 4384580
- 4442479
- 4500790
- 4504919
- 4599070
- 4645482
- 4661978
- 4680493
- 4704381
- 4742117
- 4777180
- 4801317.
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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FDA (Devices) · 2015-03-04
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- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
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- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
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