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Navilyst Medical, Inc recalls NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single us
Recalled March 4, 2015 · FDA recall Z-1163-2015 · Navilyst Medical
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. · FDA Class II
Units
5 units
Sold at
Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
Description
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.
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 Monitoring Systems.
Manufacturer(s)
Navilyst Medical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →