Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NAMIC Convenience Kit Recalled by Navilyst Medical, Inc Due to The labelled expiration dating of the affected product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Navilyst Medical, Inc directly.
Affected Products
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, 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.
Quantity: 69 units
Why Was This Recalled?
The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Navilyst Medical, Inc
Navilyst Medical, Inc has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report