Home / Recalls / Medical Devices
Navilyst Medical, Inc recalls NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only
Recalled March 4, 2015 · FDA recall Z-1201-2015 · 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
70 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, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, 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 →