Navilyst NAMIC Convenience Kit Recalled for Sterility Concerns
Navilyst Medical is recalling 13 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 is classified as FDA Class II. The hazard involves a potential sterility breach leading to an increased risk of infection, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Navilyst Medical, Inc. is recalling 13 units of NAMIC Convenience Kits (UPN H749606204751, REF/Catalog No. 60620475, Lot 4399506). 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 labelled expiration dating not being 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 units were distributed nationwide in the US, as well as in Canada and Guam.
Healthcare providers and consumers should stop using the affected product immediately. The recall is classified as Class II by the FDA.
The recalled product
- Product
- NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, 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
- Affected units
- 13
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 4399506
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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- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
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