Home / Recalls / Navilyst Medical, Inc / Z-1148-2015

Z-1148-2015 Class II Terminated

Recalled by Navilyst Medical, Inc — Glens Falls, NY

Recall Details

Product Type
Devices
Report Date
March 4, 2015
Initiation Date
January 9, 2015
Termination Date
March 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 units

Product Description

NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, 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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

Code Information

Lots 4476878, 4638166, 4677141.

Other recalls by Navilyst Medical, Inc

  • Z-1164-2015 Class II — NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, (January 9, 2015)
  • Z-1171-2015 Class II — NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, R (January 9, 2015)
  • Z-1204-2015 Class II — NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx (January 9, 2015)
  • Z-1199-2015 Class II — NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx (January 9, 2015)
  • Z-1195-2015 Class II — NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx (January 9, 2015)
  • Z-1152-2015 Class II — NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600309 (January 9, 2015)
  • Z-1189-2015 Class II — NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx (January 9, 2015)
  • Z-1194-2015 Class II — NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog N (January 9, 2015)
  • Z-1170-2015 Class II — NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx (January 9, 2015)
  • Z-1165-2015 Class II — NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. (January 9, 2015)