FDA-Device2015-03-04Class II
NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, 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
Navilyst Medical, Inc
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
Affected count
255 units
Manufactured in
10 Glens Falls Technical Park, N/A, Glens Falls, NY, United States
Products
NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2015Don't want to check this manually?
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