Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 5 units of NAMIC Convenience Kits, specifically the LEFT HEART KIT (UPN H7496007057101, REF/Catalog No. 600705710). The affected lots are 4393719, 4617238, and 4717511. These sterile, single-use 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 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. Consumers and healthcare facilities should stop using the affected lots and contact Navilyst Medical for further instructions.
The recalled product
- Product
- NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, 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…
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 5
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 (3)
- Lots 4393719
- 4617238
- 4717511.
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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