Home / Recalls / Medical Devices
Navilyst Medical, Inc recalls NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STE
Recalled March 4, 2015 · FDA recall Z-1205-2015 · 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
3 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, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, 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(s)
Navilyst Medical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →